COVID-19 Disease Treatments
The U.S. Food and Drug Administration (FDA) has evaluated various medications for treating people infected with the novel coronavirus SARS-CoV-2, which causes COVID-19 disease in humans. The FDA has granted emergency use authorizations (EUA) for certain medicines for certain patients when hospitalized with COVID-19.
On August 23, 2020, COVID-19 Convalescent Plasma, an unapproved biological product, was issued a EUA by the FDA.
On October 22, 2020, the FDA approved the antiviral drug Veklury® (remdesivir) to treat patients with COVID-19 requiring hospitalization. Gilead Sciences, Inc. announced: 'Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients.'
On November 9, 2020, the FDA issued emergency authorization for Eli Lilly's investigational monoclonal antibody therapy Bamlanivimab to treat mild-to-moderate COVID-19 in adult and pediatric patients.
Additionally, on November 21, 2020, the FDA authorized casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years of age or older weighing at least 88 pounds) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This emergency authorization includes 65 years of age or older or certain chronic medical conditions.
As of November 30, 2020, the Coronavirus Treatment Acceleration Program reported more than 590 drug development programs were in planning stages, with over 390 trials reviewed by the FDA.
On December 23, 2020, Merck announced it has entered into an agreement with the U.S. Government to support the development, manufacture, and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization from the U.S. FDA. Merck acquired MK-7110 through the acquisition of New Jersey-based OncoImmune.
Late-Stage Experimental COVID-19 Disease Therapies
Olumiant (baricitinib), an oral JAK1/JAK2 inhibitor, is evaluated in a phase 3 study in hospitalized adults with COVID-19 disease. Study investigators noted an approximately one-day reduction in median recovery time for the overall patient population treated with baricitinib combined with remdesivir versus those treated with remdesivir.
According to the RECOVERY trial, dexamethasone (glucocorticoid) reduced deaths in hospitalized patients with severe COVID-19 disease by one-third compared to those receiving usual care.
Aviptadil (RLF-100) is a formulation of synthetic human Vasoactive Intestinal Peptide, which targets the VPAC1 receptor of the ATII cell and protects that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. The U.S. FDA granted Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19.
Tradipitant may accelerate clinical improvement in hospitalized COVID-19 pneumonia patients reported a phase 3 study. Tradipitant is an experimental drug that is a neurokinin 1 antagonist. It works by blocking substance P, a small signaling molecule.
MK-7110 is a potentially first-in-class recombinant fusion protein that targets the innate immune system. In addition to the Phase 3 clinical trial for COVID-19 patients, MK-7110 has been studied for safety in healthy volunteers and Phase 2 clinical trials to prevent graft versus host disease (GVHD) following hematopoietic stem cell transplantation in patients with leukemia. A pivotal Phase 3 clinical trial (NCT04095858) for prophylaxis of GVHD has been initiated nationwide.
The U.S. FDA issued updated guidance to provide healthcare providers recommendations regarding investigational convalescent plasma collected from individuals who have recovered from COVID-19 disease. Announced on August 19, 2020, the FDA stated, ‘Convalescent plasma is being investigated for the treatment of COVID-19 because there is no approved treatment for this new disease. Emergency authorization was issued on August 23, 2020. On November 16, 2020, the FDA's new guidance included a new recommendation that authorized COVID-19 convalescent plasma not to be collected from individuals who have received an investigational COVID-19 vaccine.
Early-Stage Experimental COVID-19 Therapies
Molnupiravir (MK-4482/EIDD-2801) is an oral antiviral medication originally developed to treat influenza. MK-4482/EIDD-2801 consists of the nucleoside analog N4-hydroxycytidine. Molnupiravir has been evaluated against coronaviruses, suppressing virus transmission within 24-hours.
CytoDyn's Leronlimab is in early clinical trials to treat COVID-19 disease. Leronlimab is intended to serve as a therapy for patients who experience respiratory illness due to contracting the Coronavirus Disease 2019 (COVID-19). CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S., and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.
Vir and GSK's VIR-7831 (GSK4182136) is a single-dose monoclonal antibody that can prevent hospitalization due to COVID-19 disease.
AstraZeneca's AZD7442 long-acting antibody combination (LAAB) is launching late-stage clinical studies in various countries. The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.
Roche and Atea's AT-527 has demonstrated clinical safety/tolerability and potent antiviral efficacy in patients with HCV infection, as well as a favorable human pharmacokinetic profile, with potent in vitro activity against human coronaviruses.
January 2021 COVID-19 Treatment News
January 21, 2021 - Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents. After all, participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo (odds ratio 0.43, p=0.00021). All key secondary endpoints also reached statistical significance in both the overall and resident populations. An independent data and safety monitoring board oversaw the BLAZE-2 trial. In the trial, the safety profile of bamlanivimab was consistent with observations from the Phase 1 and Phase 2 trials. Serious adverse events were reported at a similar frequency in the bamlanivimab and placebo groups. Across multiple clinical trials, Lilly now has collected safety and efficacy data in more than 4,000 patients treated with bamlanivimab, either alone or administered together with another antibody. "The results of this innovative study further support the belief that bamlanivimab – and potentially other monoclonal antibodies – can reduce symptoms and may even prevent COVID-19," said Myron S. Cohen, M.D., CoVPN co-principal investigator, and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill.
January 19, 2021 - Study published by The Lance: Among patients with non-severe COVID-19 and no risk factors for severe disease receiving a single 400 mcg/kg dose of ivermectin within 72 hours of fever or cough onset, there was no difference in the proportion of PCR positives. There was, however, a marked reduction of self-reported anosmia/hyposmia, a reduction of cough, and a tendency to lower viral loads and lower IgG titers, which warrants assessment in larger trials. The positive signal found in this pilot, together with emerging evidence from animal models and other clinical trials, warrants the conduction of larger trials using ivermectin for the early treatment of COVID-19. This pilot study has several key limitations that warrant careful interpretation of the results.
January 18, 2021 - Barcelona-based Grifols announced it would begin a clinical trial to evaluate a new COVID-19 drug's safety and efficacy based on the Grifols immunoglobulin Gamunex®-C and containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.
January 18, 2021 - Key Capital Corp announced that current independent laboratory testing of its partnered Immunitor COVID-19 patented oral pill vaccine in an ongoing university study provides promising early support for the vaccine's safety and efficacy. The preliminary tests conducted by a leading Asian research institute have shown safety and a 90% reduction in virus infectivity in mammalian cells following exposure to the active vaccine. This laboratory testing highlights the vaccine methodology and ability to inactivate and/or prevent viral infection and its potential for oral mucosal administration.
January 13, 2021 - Study by Mayo Clinic researchers published by the NEJM: Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19. CONCLUSIONS: Among patients hospitalized with Covid-19 who were not receiving mechanical ventilation, transfusion of plasma with higher anti–SARS-CoV-2 IgG antibody levels were associated with a lower risk of death transfusion of plasma with lower antibody levels.
January 13, 2021 - The NEJM published an editorial by Mayo Clinic researcher Louis M. Katz, M.D.: A Little Clarity on Convalescent Plasma for Covid-19.
January 13, 2021 - The UK based Synairgen plc announced that the first patient had been dosed in the UK due to its global Phase III trial (SG018) evaluating Synairgen’s inhaled formulation interferon beta-1a (SNG001) for the treatment of hospitalized COVID-19 patients. Synairgen’s SG018 trial is a randomized placebo-controlled study conducted in approximately 20 countries, enrolling 610 COVID-19 patients who require supplemental oxygen. SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA) in the US. The Company is seeking further equivalent prioritisations and support from governments in participating countries.
January 12, 2021 - Regeneron Pharmaceuticals, Inc. announced that the U.S. government would purchase an additional supply of the casirivimab and imdevimab antibody cocktail for use non-hospitalized COVID-19 patients to meet the federal government's Operation Warp Speed goals. The government has said it will provide these doses at no cost to patients, though healthcare facilities may charge administration fees. The new agreement covers 1.25 million additional doses of the casirivimab and imdevimab antibody cocktail, bringing the total potential U.S. supply to over 1.5 million doses.
January 12, 2021 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in Phase 1b/2a clinical trial. VIR-7832 is a neutralizing COVID-19 antibody that preclinical data suggests has two distinguishing properties: an enhanced ability to clear infected cells and the potential to enhance virus-specific T-cell function, which could help treat and/or prevent COVID-19 infection.
January 6, 2021 - Therapies to interrupt early COVID-19) remain elusive, stated researchers in a study published by the NEJM. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness. In the intention-to-treat population, the severe respiratory disease developed in 13 of 80 patients (16%) who received convalescent plasma and 25 of 80 patients (31%) who received placebo, with a relative risk reduction of 48%.
January 4, 2021 - aTyr Pharma, Inc. announced positive topline results from its Phase 2 double-blind, placebo-controlled clinical trial of its lead therapeutic candidate, ATYR1923, hospitalized COVID-19 patients with severe respiratory complications who do not require mechanical ventilation. The trial met its primary endpoint of safety, demonstrating that a single intravenous dose of ATYR1923 was generally safe and well-tolerated in both the 1.0 and 3.0 mg/kg treatment groups, with no drug-related serious adverse events.
January 4, 2021 - London and New York-based Tiziana Life Sciences plc announced the completion of its clinical study in Brazil investigating nasally administered Foralumab, its proprietary human monoclonal antibody, either alone or in combination with orally administered dexamethasone in COVID-19 patients. The topline data from the trial is expected to be available in January 2021. Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows a reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab.
January 4, 2021 - Massacheuttes based Kaleido Biosciences, Inc. announced the completion of enrollment of 350 subjects in the controlled clinical study K031 evaluating Microbiome Metabolic Therapy (MMT™) candidate KB109 in the treatment of mild-to-moderate COVID-19. The multi-center, non-IND clinical study is designed to evaluate the effects of KB109 plus supportive self-care (SSC) compared to SSC alone for outpatients who are positive for SARS-Cov-2 and have symptoms.
December 2020 COVID-19 Treatment News
December 31, 2020 - A novel computational drug screening strategy combined with lab experiments suggest that pralatrexate, a chemotherapy medication originally developed to treat lymphoma, could potentially be repurposed to treat Covid-19. Haiping Zhang of the Shenzhen Institutes of Advanced Technology in Shenzhen, China, and colleagues present these findings in the open-access journal PLOS Computational Biology.
December 30, 2020 - Bausch Health Companies Inc. announced that the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland had granted an additional new indication for DEXAVEN (dexamethasone phosphate) solution for injection, 4 mg/ml, for the treatment of COVID-19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who require oxygen therapy. DEXAVEN is a corticosteroid that reduces inflammation.
December 29, 2020 - Regeneron Pharmaceuticals announced the therapy's initial data in hospitalized COVID-19 patients requiring low-flow oxygen as encouraging. According to Regeneron's press statement, the study's results have passed the futility analysis with seronegative patients treated having a lower risk of death or receiving mechanical. And in seronegative patients, the antibody cocktail reduced the time-weighted average daily viral load.
December 25, 2020 - Researchers in the STORM CHASER study led by UCLH virologist Dr. Catherine Houlihan has recruited the first participant in the world to the study. They believe the antibody or LAAB, known as AZD7442 and developed by AstraZeneca, may offer immediate and long-term protection to people who have been recently exposed to the SARS-CoV-2 virus to prevent them from developing Covid-19. Dr. Houlihan said: “We know that this antibody combination can neutralize the virus, so we hope to find that giving this treatment via injection can lead to immediate protection against the development of Covid-19 in people who have been exposed – when it would be too late to offer a vaccine.”
December 24, 2020 - AIM ImmunoTech Inc. announced today that the post-COVID-19 “Long-Hauler” portion of the active AMP-511 Expanded Access Program protocol received approval from the Institutional Review Board for public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen.
December 24, 2020 - CytoDyn Inc. announced today the U.S. Food and Drug Administration guided the Company through adding an open-label extension to its Phase 3 trial (“CD12”) and specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12. The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12. The CD12 trial completed enrollment with 394 patients on December 16, 2020.
December 22, 2020 - RedHill Biopharma Ltd. announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia had received a second unanimous recommendation to continue, following a second independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's recommendation is based on an analysis of unblinded safety data from the first 155 patients treated for 14 days.
December 22, 2020 - Kiniksa Pharmaceuticals, Ltd. announced data from the investigator-initiated placebo-controlled study of mavrilimumab in patients with severe COVID-19 pneumonia and hyperinflammation. Data showed an early signal of efficacy, with trends toward clinical improvement and lower mortality, and shorter mechanical ventilation duration in patients treated with mavrilimumab on top of corticosteroids, including dexamethasone remdesivir.
December 21, 2020 - Innovation Pharmaceuticals announce that the U.S. FDA has approved the Company’s Investigational New Drug application to proceed with the initiation of Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2 and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment.
December 17, 2020 - The NEJM published a study: Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia, which concluded saying 'In hospitalized patients with Covid-19 pneumonia who were not receiving mechanical ventilation, tocilizumab reduced the likelihood of progression to the composite outcome of mechanical ventilation or death, but it did not improve survival. No new safety signals were identified.' A total of 389 patients underwent randomization, and the modified intention-to-treat population included 249 patients in the tocilizumab group and 128 patients in the placebo group. Death from any cause by day 28 occurred in 10.4% of the patients in the tocilizumab group and 8.6% of those in the placebo group (weighted difference, 2.0 percentage points; 95% CI, –5.2 to 7.8). In the safety population, serious adverse events occurred in 38 of 250 patients (15.2%) in the tocilizumab group and 25 of 127 patients (19.7%) in the placebo group.
December 17, 2020 - Study: REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose and placebo groups.
December 17, 2020 - Ontario-based Vasomune Therapeutics, Inc. announced the first subjects had been dosed in a Phase 1 study of AV-001 in healthy subjects. AV-001 is a first-in-class therapeutic that targets the Tie2 tyrosine kinase receptor, a key regulatory protein in the vasculature responsible for maintaining normal vascular function. Should the benefit demonstrated in animal studies translate to the clinic, AV-001 has the potential to improve survival and shorten the duration of hospitalization for patients hospitalized with COVID-19.
December 17, 2020 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced that the first patient had been dosed in a new sub-trial of the U.S. NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. Antibodies can prevent viruses from infecting cells, sometimes binding to the viruses' surface. Synthetic versions of these antibodies, prepared in a laboratory, are known as monoclonal antibodies.
December 17, 2020 - CalciMedica Inc. announced that the trial evaluating AuxoraTM in patients with severe COVID-19 pneumonia had received a recommendation to continue, following a pre-scheduled safety review by an Independent Data Monitoring Committee. The IDMC recommendation that the trial continue is based on an unblinded analysis of safety data from over 50 patients. The company expects to have more than 100 patients enrolled by the end of December 2020.
December 15, 2020 - INOVIO announced the company and a team of scientists from The Wistar Institute, AstraZeneca, the University of Pennsylvania, and Indiana University received a $37.6 million grant from the U.S. Defense Advanced Research Projects Agency to use INOVIO's innovative DNA-encoded monoclonal antibody (dMAb®) technology to develop anti-SARS-CoV-2-specific dMAbs which could offer versatile capabilities to function as both a therapeutic and preventive treatment for COVID-19.
December 15, 2020 - ARCA biopharma, Inc. announced that the first patients had been enrolled in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 (AB201) as a potential treatment for patients hospitalized with COVID-19. The first patient was enrolled at the University of Colorado Hospital on December 10, 2020, with a total of 5 patients randomized to date. The Company currently anticipates topline trial data from this Phase 2b clinical trial in the second quarter of 2021.
December 15, 2020 - Canada based Algernon Pharmaceuticals Inc. reported in a descriptive format positive trending interim data for the Phase 2b part of the Company’s Phase 2b/3 clinical study Ifenprodil for COVID-19. For the endpoint of ventilation by day 15, there was a trend towards fewer patients requiring mechanical ventilation in the high dose Ifenprodil treatment arm than patients in the study's untreated vary. Mechanical ventilation is associated with poor prognosis in COVID-19 patients, including an increased risk of mortality and procedural complications. (1) Also, the extended duration of mechanical ventilation places an enormous burden on ICUs and entire hospital systems.
December 11, 2020 - A study published by the journal Nature reported, 'We identify potential targets for the repurposing of licensed medications: using Mendelian randomization, we found evidence in support of a causal link from a low expression of IFNAR2, and high expression of TYK2, to life-threatening disease; transcriptome-wide association in lung tissue revealed that high expression of the monocyte/macrophage chemotactic receptor CCR2 is associated with severe Covid-19. Our results identify robust genetic signals relating to key host antiviral defense mechanisms and mediators of inflammatory organ damage in Covid-19. Both mechanisms may be amenable to targeted treatment with existing drugs. However, large-scale randomized clinical trials will be essential before changing clinical practice.
December 11, 2020 - A study published by the NEJM found the results of this randomized, double-blind, placebo-controlled trial show that combination treatment with the anti-inflammatory drug baricitinib and the antiviral drug remdesivir was safe and superior to remdesivir alone for the treatment of hospitalized patients with Covid-19 pneumonia. The combination treatment's beneficial effects were seen in the primary outcome, with a 1-day shorter time to recovery, with greater clinical status improvement as assessed on the ordinal scale, in the key secondary outcomes. Although ACTT-2 was not powered to detect a difference in mortality between the two groups, both the survival and time-to-death analyses favored combination treatment.
December 9, 2020 - Sorrento Therapeutics, Inc. announced the U.S. FDA acceptance of its Investigational New Drug (IND) application for its Phase 1 clinical trials for intravenous (IV) STI-2020 (COVI-AMG). The trials will evaluate the safety, pharmacokinetics, and efficacy of a single injection of STI-2020 in healthy volunteers and outpatient COVID-19 patients with mild symptoms. Sorrento previously announced that STI-2020 demonstrated a complete neutralizing effect at a shallow dose in preclinical studies and high potency that may potentially enable rapid deployment and availability to patients. Sorrento has initiated cGMP manufacturing to produce up to 100,000 doses in anticipation of a potential EUA.
December 8, 2020 - Cyxone announced it had received approval from the regulatory authority and the ethics committee in Poland to initiate a Phase 2 clinical trial with Rabeximod in moderate Covid-19 patients. The oral treatment is intended to prevent the progression to acute respiratory distress symptoms (ARDS) caused by virus-related overactivation of the immune system. Preliminary results are expected in the third quarter of 2021.
December 3, 2020 - Study: Treatment of infected animals with MK-4482/EIDD-2801 twice a day significantly reduced the SARS-CoV-2 load in the upper respiratory tract and completely suppressed spread to untreated contact animals. This study identified oral MK-4482/EIDD-2801 as a promising antiviral countermeasure to break SARS-CoV-2 community transmission chains.
December 3, 2020 - Boston-based PureTech Health plc announced the initiation of its global, Phase 2 trial of LYT-100 (deupirfenidone) in Long COVID respiratory complications and related sequelae. LYT-100 is PureTech’s wholly-owned product candidate advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow. The initiation follows the completion of a Phase 1 multiple ascending doses and food effect study for LYT-100, which demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic profile.
December 03, 2020 - Israel based Enlivex Therapeutics Ltd. reported positive interim results of an investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. The interim clinical results relate to eight COVID-19 patients treated with Allocetra in Phase II clinical trial, six of whom were in severe condition, and two were in critical condition.
December 2, 2020 - CVS Health was selected today by the U.S. Department of Health and Human Services (HHS), as part of Operation Warp Speed, to pilot the administration of a limited supply of bamlanivimab, a monoclonal antibody therapy, with eligible COVID-19 patients who are at risk of severe infection or complications resulting from the coronavirus. Under this pilot, Coram, the specialty pharmacy and infusion care business of CVS Health, will administer intravenous therapy in patients’ homes or long-term care facilities to meet the growing demand for these new treatments.
December 1, 2020 - Auris Medical Holding Ltd. announced positive efficacy data from testing AM-301 in vitro. AM-301 is a drug-free nasal spray developed by the Company’s affiliate Altamira Medica for protection against airborne pathogens and allergens.
November 2020 COVID-19 Treatment News
November 30, 2020 - Maryland based NeoImmuneTech, Inc. announced that the first patient had been dosed in the company’s Phase 1 study evaluating NT-I7 (efineptakin alfa), a novel long-acting human IL-7, in adult patients with mild COVID-19. The company-sponsored trial is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the University of Nebraska Medical Center. NgocDiep Le, M.D., Ph.D., EVP and CMO of NeoImmuneTech stated: “NT-I7 has been shown to restore lymphocyte counts in cancer patients, which also appears to be essential for patients battling viral illnesses such as COVID-19 where low lymphocyte count is strongly associated with poor clinical outcomes. We believe that NT-I7 has the potential to reinvigorate patients’ immune systems to mount stronger responses to this aggressive infection.”
November 30, 2020 - Ontario based Edesa Biotech, Inc. announced that the first patient had been enrolled in a Phase 2/3 clinical trial evaluating the company's investigational drug, EB05, a clinical-stage monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome, the leading cause of death in COVID-19 patients. EB05 is delivered intravenously in a single infusion to hospitalized COVID-19 patients.
November 29, 2020 - The anti-inflammatory treatment Colchicine was added to the Randomised Evaluation of COVid-19 thERapY study, the world’s largest clinical trial of treatments for patients hospitalized with COVID-19.
November 24, 2020 - California based Capricor Therapeutics, Inc. announced today that the first two patients had been dosed in its Phase 2 study evaluating intravenous infusion of CAP-1002, using its allogeneic cardiosphere-derived cells (CDC) technology as a treatment option for patients with COVID-19.
November 24, 2020 - Indiana-based Vivacelle Bio, Inc. announced the Department of Defense awarded $5.3 million for the clinical trial of VBI-S, an intravenously injected fluid for septic treatment shock due to various pathogens, including COVID-19, other viruses, and/or bacteria. Approximately 270,000 people in the USA and 10 million people worldwide die of septic shock annually. And, about 70% of COVID deaths are due to septic shock.
November 23, 2020 - Merck announced it would accelerate the development of CD24Fc, a candidate for treating patients with severe and critical COVID-19. Interim analysis of data from 203 participants (75% of the planned enrollment) reported by OncoImmune indicated that patients with severe or critical COVID-19 treated with a single dose of CD24Fc showed a 60% higher probability of improvement in clinical status, as defined by the protocol, compared to placebo. The risk of death or respiratory failure was reduced by more than 50%. OncoImmune’s lead product is CD24Fc, a first-in-class recombinant fusion protein that targets the innate immune system. Before the Phase 3 clinical trial for COVID-19 patients, CD24Fc has been studied for safety in healthy volunteers and Phase 2 clinical trials to prevent graft versus host disease (GVHD) following hematopoietic stem cell transplantation in patients with leukemia.
November 23, 2020 - HiFiBiO Therapeutics announced a partnership with Russian pharmaceutical company Pharmsynthez PJSC and Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS. The partnership aims to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19, through clinical development and commercial sale in Russia.
November 19, 2020 - The U.S. FDA issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. In a clinical trial of hospitalized patients with COVID-19, baricitinib, combined with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.
November 16, 2020 - The U.S. FDA updated its guidance on investigational COVID-19 convalescent plasma, extending the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma to treat hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the EUA.
November 16, 2020 - RedHill Biopharma Ltd. announced that the U.S. Phase 2 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia had completed enrollment of the last patient in the study. The study is not powered for statistical significance. Topline data is expected in the coming weeks.
November 16, 2020 - Innovation Pharmaceuticals announced that an overseas Clinical Trial Application had been submitted to the governing health agency, with a U.S. Investigational New Drug application to be submitted this week to the FDA. Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.
November 16, 2020 - Abpro Corporation announced the publication of a peer-reviewed article in the scientific journal Nature Communications titled, “Characterization of neutralizing antibody with prophylactic and therapeutic efficacy against SARS-CoV-2 in rhesus monkeys.”
November 13, 2020 - Governor Greg Abbott today announced that the Texas Department of State Health Services (DSHS) is allocating an initial shipment of bamlanivimab, the Eli Lilly & Company monoclonal antibody therapy, to be distributed as early as next week to acute care hospitals across every geographic region of the state. DSHS will allocate this initial distribution of bamlanivimab based on three criteria: new confirmed cases of COVID-19 in the community, new lab-confirmed COVID-19 admissions to hospitals, and total lab-confirmed COVID-19 patients in hospitals.
November 13, 2020 - the UK based Synairgen plc announced data from the Company’s SG016 trial in The Lancet Respiratory Medicine journal. Patients receiving SNG001 had greater odds of improvement across the OSCI scale (OR 2·32; 95% CI: 1·07, 5·04; p=0·033) and were more likely to recover to “no limitation of activity” during treatment (HR 2·19; 95% CI: 1·03, 4·69; p=0·043). There were three deaths in the placebo group and none in the SNG001 group.
November 12, 2020 - A Washington University School of Medicine study of COVID-19 patients with mild-to-moderate disease who were attempting to recover in their homes found that the drug fluvoxamine 'seems to prevent some of the most serious complications of the illness and make hospitalization and the need for supplemental oxygen-less likely.'
November 12, 2020 - Vasomune Therapeutics, Inc., announced the U.S. FDA had allowed its Investigational New Drug application for AV-001, a novel investigational medicine that targets the Tie2 receptor, a transmembrane protein target most highly expressed on the surface of endothelial cells in the vasculature. AV-001 activates the Tie2-Angiopoietin pathway and restores normal vascular function and endothelial stability. Vascular dysfunction contributes to the underlying disease pathophysiology in patients with COVID-19 and acute respiratory distress syndrome (ARDS), especially in patients with preexisting vascular comorbidities, such as hypertension, diabetes, and obesity.
November 11, 2020 - Sorrento Therapeutics announced that it is filing an investigational new drug application for intranasal COVI-DROPS (STI-2099) to study the safety pharmacokinetics of both healthy volunteers and patients with mild COVID-19. Sorrento previously announced in preclinical studies that high potency STI-2099 demonstrated a 100% neutralizing effect (both in vitro and in vivo). At a shallow dose, it prevented SARS-CoV-2 from infecting healthy cells and causing COVID-19-like disease in Syrian golden hamsters. “We believe STI-2099 has the potential to be broadly deployable for early treatment in an outpatient setting. The intranasal route is expected to be enabled by the high potency of the antibody and is quite promising against this highly contagious respiratory pathogen,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics.
November 9, 2020 - British Columbia-based AbCellera announced that bamlanivimab (LY-CoV555) 700 mg, a human antibody developed through AbCellera’s collaboration with Eli Lilly and Company, has received emergency use authorization from the U.S. FDA.
November 9, 2020 - California based Sorrento Therapeutics, Inc. announced that it is filing an investigational new drug application for intravenous COVI-AMG (STI-2020) to treat COVID-19 patients with mild symptoms and to evaluate safety and pharmacokinetics in healthy volunteers. And Sorrento has initiated cGMP manufacturing to produce 100,000 doses, expected to be available in 2021. This antibody has been engineered for ultra-high potency, with an expected effective dose in humans to be much lower than current known antibodies being assessed by others in active trials, allowing for a simple IV-push administration is suitable in the outpatient setting.
November 6, 2020 - Novartis announced the Phase III trial investigating canakinumab plus standard of care (SoC) did not meet its primary endpoint of a greater chance of patient survival without the need for invasive mechanical ventilation, or its key secondary endpoint of reduced COVID-19 mortality, compared with SoC.
November 6, 2020 - Vir Biotechnology, Inc. announced the publication of new research demonstrating that the immunodominant SARS-CoV-2 receptor binding motif is the least conserved region in the SARS-CoV-2 spike protein, allowing for the occurrence of mutations without disrupting human ACE2 (hACE2) binding, which mediates viral entry.
November 2, 2020 - Immunic, Inc. announced that the company has enrolled and randomized 200 patients, pre-specified in the protocol as sufficient to perform the main efficacy analysis of the phase 2 part of the CALVID-1 trial for its selective oral DHODH inhibitor, IMU-838, in hospitalized patients with moderate COVID-19. The CALVID-1 trial aims to investigate IMU-838 as an oral treatment option and to support the potential use of IMU-838 as a treatment for current and potential future viral pandemic threats. The trial is being conducted under an investigational new drug application granted by the U.S. FDA using a single global protocol with clinical sites in the USA, Germany, and a range of other European countries.
October 2020 COVID-19 Treatment News
October 29, 2020 - Humanigen, Inc. announced that the first patient had been dosed at the Emory University School of Medicine in Atlanta, Georgia, as part of the ACTIV-5 “Big Effect Trial” evaluating lenzilumab with remdesivir, compared to placebo and remdesivir, in patients hospitalized with COVID-19. Lenzilumab is the Company’s lead product candidate and proprietary Humaneered®anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody designed to optimize antibody properties.
October 28, 2020 - Novartis and Molecular Partners AG announced a collaboration in the form of an option and license agreement to develop, manufacture, and commercialize Molecular Partners’ anti-COVID-19 DARPin® program, consisting of two therapeutic candidates, MP0420 and MP0423.
October 28, 2020 - Boehringer Ingelheim announced the initiation of Phase 2 clinical trial of BI 764198, an inhibitor of TRPC6, a receptor-operated cation channel. This potent and selective inhibitor of TRPC6 may alleviate the lung's damage and decrease the risk or severity of acute respiratory complications in patients hospitalized for COVID-19.
October 28, 2020 - Eli Lilly announced an agreement with the U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody. The initial agreement is for delivery over the 2-months following authorization and also provides the option for the U.S. government to purchase up to an additional 650,000 vials through June 30, 2021.
October 27, 2020 - Efforts are underway at the Uniformed Services University of the Health Sciences to support the fight against the pandemic. They focus on how short segments of non-coding RNAs can interfere with protein formation, reduce inflammation, and ultimately suppress the virus. Some of these RNAs are designed to target the virus itself directly. ''Our goal is to suppress inflammatory proteins, like Interleukins (IL-6, IL-8, IL-1-), which play a major role in the damage caused by SARS-CoV-2."
October 26, 2020 - France based Biophytis SA announced that the first patient in Brazil had been dosed at Hospital e Maternidade Celso Pierro - PUCCAMP in Campinas in COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the treatment of patients with COVID-19-related respiratory failure. The multinational trial is progressing at pace, with ten centers now open to recruiting patients in Belgium, France, Brazil, and the USA.
October 26, 2020 - Nitric Oxide Innovations LLC announced it had received Investigational New Drug clearance as part of the Coronavirus Treatment Acceleration Program from the U.S. FDA to begin a Phase 2b/3a outpatient clinical study testing the safety and efficacy of its new drug, NOviricid, 30 mg sodium nitrite dosing in an oral lozenge. NOviricid is the first oral Nitric Oxide generating drug to be clinically tested to treat African Americans diagnosed with COVID-19.
October 26, 2020 - ANA Therapeutics announced that it had begun a multicenter, Phase 2/3 clinical trial to evaluate the safety and efficacy of its proprietary, oral niclosamide (ANA001) formulation for the treatment of patients with moderate COVID-19 disease.
October 26, 2020 - HiFiBiO Therapeutics announced the successful completion of the first cohort of the Phase I study of HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment and prevention of COVID-19.
October 22, 2020 - Serum Institute of India Pvt. Ltd. announced an agreement with Merck to develop SARS-CoV-2 neutralizing monoclonal antibodies co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic.
October 22, 2020 - Atea Pharmaceuticals, Inc. announced it has entered into an agreement with Roche for the exclusive rights to research, develop and distribute AT-527 as an oral antiviral treatment for COVID-19 territories outside of the United States.
October 22, 2020 - A study published by the BMJ stated 'Convalescent plasma was found not associated with a reduction in progression to severe covid-19 or all-cause mortality. This trial has high generalisability and approximates convalescent plasma use in real-life settings with limited laboratory capacity. A priori measurement of neutralizing antibody titers in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.'
October 22, 2020 - Aerogen announced an agreement with Synairgen plc to provide the market-leading Aerogen® Solo/Ultra nebulizer system to deliver SNG001 directly into the lungs directly COVID-19 patients.
October 21, 2020 - NIH Director Dr. Francis Collins and National Center for Advancing Translational Sciences Director Dr. Chris Austin discuss ACTIV-1, a large-scale clinical trial to test 3 immune modulators to treat COVID-19, on YouTube.
October 21, 2020 – Denmark based UNION therapeutics A/S announces the expansion of the clinical pipeline to prevent COVID-19 and reduce the severity of the diseases among those already infected. The nasal spray product, UNI91103, has been successfully tested in 44 healthy volunteers without significant safety concerns and is ready for tests in COVID-19 patients as well as subjects at risk of contracting COVID-19.
October 21, 2020 - Beyond Air, Inc. announced plans to initiate a phase 1 clinical study of the LungFit system to evaluate the safety and efficacy of high concentration inhaled Nitric Oxide given intermittently to adults hospitalized with acute viral pneumonia, including SARS-CoV-2. The study will take place in Israel and be a multi-center, open-label, randomized clinical trial with approximately 90 adult patients.
October 20, 2020 - Appili Therapeutics Inc. announced that investigators enrolled and dosed the first cluster of participants in Appili’s CONTROL COVID-19 phase 2 clinical trial, a cluster-randomized placebo-controlled study is evaluating the effectiveness of favipiravir as a preventative measure against COVID-19 in long-term care facilities.
October 16, 2020 - Arch Biopartners Inc. announced it had dosed the first patient in the Phase II trial of its lead drug LSALT peptide, targeting the prevention of acute lung injury, acute kidney injury, and other complications caused by inflammation in hospitalized patients with moderate to severe cases of COVID-19.
October 9, 2020 - AstraZeneca announced it received around $486 million from the US Government to develop and supply AZD7442, its experimental long-acting antibody combination. Additionally, AstraZeneca stated clinical trials of AZD7442 would enroll over 6,000 adults to prevent COVID-19, with additional trials enrolling about 4,000 adults for the treatment of SARS-CoV-2 infections.
October 8, 2020 - The U.S. NIH announced a clinical trial to test the safety, tolerability, and efficacy of a combination treatment regimen for COVID-19 consisting of the antiviral Veklury (remdesivir) plus a highly concentrated solution of antibodies that neutralize the SARS-CoV-2 coronavirus is taking place in hospitalized adults with COVID-19 in the USA, Mexico, and 16 other countries. The antibody solution being tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin or hIVIG. The antibodies in anti-coronavirus hIVIG come from the liquid portion of blood, or plasma, donated by healthy people who have recovered from COVID-19.
October 7, 2020 - Eli Lilly announced additional details on its SARS-CoV-2 neutralizing antibody programs – including interim data on combination therapy in recently diagnosed patients with mild-to-moderate COVID-19 – and planned to make these therapies broadly available to patients. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 and LY-CoV016, which binds complementary regions of the SARS-CoV-2 spike protein treatment symptomatic COVID-19 in the outpatient setting. The combination cohort enrolled recently diagnosed patients with mild-to-moderate COVID-19, who were assigned to 2800 mg of each antibody (n=112) or placebo (n=156).
October 7, 2020 - ARCA biopharma, Inc. announced the U.S. FDA had approved the Investigational New Drug application for AB201 (rNAPc2) as a potential treatment for patients hospitalized with COVID-19. ARCA anticipates initiating a Phase 2b/3 sequential clinical trial, ASPEN-COVID-19, of AB201 in approximately 100 patients hospitalized with COVID-19 in the fourth quarter of this year, with Phase 2b followed by a contiguous Phase 3 study that is dependent on Phase 2 results. The Company anticipates publishing topline data from the trial in the second quarter of 2021.
October 06, 2020 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 monoclonal antibody selected based on its potential to neutralize the virus and kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs. Following a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee, the COMET-ICE registrational study will expand globally to additional North America, South America, and Europe sites.
October 5, 2020 - Study published in The Lancet: In patients admitted to hospital with COVID-19, lopinavir-ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support lopinavir-ritonavir's use to treat patients admitted to a hospital with COVID-19.
October 5, 2020 - The U.S. FDA announced it awarded a new research contract to the Stanford University School of Medicine to perform an in-depth analysis of tissue samples to learn more about SARS-CoV-2—the virus that causes COVID-19—affects different systems in the body, and identify immune correlates. This regulatory science project could help inform the development and evaluation of medical countermeasures for COVID-19.
October 5, 2020 - A Living Systematic Review for an American College of Physicians Practice Points: In hospitalized adults with COVID-19, remdesivir probably improves recovery and reduces serious adverse events, and may reduce mortality and time to clinical improvement. A 5-day course of remdesivir may provide similar benefits to and fewer harms than a 10-day course for adults not receiving mechanical ventilation or extracorporeal membrane oxygenation.
October 5, 2020 - Corvus Pharmaceuticals announced updated data from its ongoing Phase 1 study CPI-818 investigating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19. The 56-day follow-up results showed a dose-response, with higher and more prolonged titers of anti-SARS-CoV-2 antibodies in the 1.0 mg/kg cohort than the 0.3 mg/kg cohort. The results also showed increased memory B cells and memory T cells.
October 2, 2020 - Regeneron Pharmaceuticals, Inc. confirmed that it provided a single 8-gram dose of REGN-COV2, a cocktail of two monoclonal antibodies, for President Trump provided in response to an Individual Patient Investigational New Drug application submitted by the President’s physicians.
October 1, 2020 - The FDA revised its Emergency Use Authorization (EUA) to reflect changes in the distribution and allocation of the antiviral drug Veklury (remdesivir).
September 2020 COVID-19 Treatment News
September 29, 2020 - Regeneron Pharmaceuticals, Inc. announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits. The ongoing, randomized, double-blind trial measures the effect of adding REGN-COV2 to the usual standard-of-care.
September 29, 2020 - Scott Sigman, M.D. announced the publication of a second case report demonstrating positive outcomes for a COVID-19 patient treated with laser therapy. Published in the Canadian Journal of Respiratory Therapy, the article describes a remarkable decrease in inflammatory markers, IL-6 and Ferratin, and marked improvement in radiological findings after supportive treatment with Photobiomodulation Therapy.
September 28, 2020 - Sorrento Therapeutics, Inc. released preclinical data reporting on COVI-GUARD™ (STI-1499) and COVI-AMG™ (STI-2020; Affinity Matured COVI-Guard) neutralizing antibodies (nAbs) against SARS-CoV-2 as well as a D614G virus variant infection. Both demonstrated potent neutralizing activities against SARS-CoV-2 virus infection in preclinical models. The FDA has cleared STI-1499 nAb for a Phase 1 clinical trial in hospitalized COVID-19 patients. STI-2020 is an affinity-matured version of the COVI-GUARD nAb and has demonstrated a greater than 50-fold increase in potency in vitro experiments.
September 28, 2020 - Eiger BioPharmaceuticals, Inc. announced results of an investigator-sponsored study of Peginterferon Lambda-1a (Lambda) in outpatients with mild and uncomplicated COVID-19.
September 28, 2020 - FSD Pharma Inc. announced that the U.S. FDA had authorized the initiation of a Phase 2 study to use FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat hospitalized COVID-19 patients. FSD201 is formulated as a tablet for oral dosing and is a safe compound with no known serious adverse side effects.
September 25, 2020 - The National Institutes of Health COVID-19 Treatment Guidelines Panel published in the Annals of Internal Medicine says, 'Taking everything into account, the Panel has determined that the data are currently insufficient to recommend for or against convalescent plasma for treating COVID-19.'
September 23, 2020 - Humanigen, Inc. announced a strategic collaboration with Thermo Fisher Scientific, a world leader in serving science, to expand the manufacturing capacity for lenzilumab, currently in a Phase 3 registration study in patients with COVID-19, to support a potential Emergency Use Authorization.
September 22, 2020 - RedHill Biopharma Ltd. announced approval from the Brazilian Health Regulatory Agency for its ongoing global Phase 2/3 study evaluating opaganib in patients hospitalized with severe COVID-19 pneumonia.
September 17, 2020 - Genentech announced that the Phase III EMPACTA study met its primary endpoint, showing patients with COVID-19 associated pneumonia who received Actemra® (tocilizumab) plus standard care were 44% less likely to progress to mechanical ventilation or death. The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.
September 16, 2020 - Eli Lilly announced proof-of-concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced hospitalization rate for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, to treat symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2800 mg, and 7000 mg).
September 16, 2020 - Algernon Pharmaceuticals Inc. announced that the external Data and Safety Monitoring Board has unanimously approved its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) the treatment of COVID-19.
September 16, 2020 - Sorrento Therapeutics announced that it received a 'study may proceed letter' from the U.S. FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients. In preclinical studies, Sorrento previously announced that STI-1499 demonstrated a 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies. STI-1499 was further evaluated in preclinical studies using multiple SARS-CoV-2 strains, including the highly contagious D614G variant. In these preclinical studies, the antibody has been 100% effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain.
September 15, 2020 - Innovation Pharmaceuticals reported receiving additional data from a U.S. Regional Biocontainment Laboratory (RBL) collected during ongoing in vitro testing supporting Brilacidin as a potential treatment SARS-CoV-2, the novel coronavirus responsible for COVID-19. In human lung epithelial cell line experiments performed at the RBL, Brilacidin, combined with Remdesivir, compared to Remdesivir-only treated conditions, showed statistically significant and synergistic inhibition SARS-CoV-2. Of particular note, overall viral load was reduced by 99.85 percent in one combination experiment, with the remaining coronavirus dropping to nearly undetectable levels.
September 14, 2020 - Regeneron Pharmaceuticals, Inc. and the University of Oxford today announced the RECOVERY (Randomised Evaluation of COVid-19 thERapY) clinical trials would evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. REGN-COV2 comprised two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically by Regeneron scientists to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
September 14, 2020 - Eli Lilly and Incyte announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2), which included more than 1,000 patients and began on May 8th to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib, in combination with remdesivir, met the primary endpoint of reduction of time to recovery compared to remdesivir. Study investigators noted an approximately 1-day reduction in median recovery time for the overall patient population treated with baricitinib combined with remdesivir versus those treated with remdesivir. This finding was statistically significant.
September 14, 2020 - Mateon Therapeutics announced that its global study based on its ARTI-19 protocol for Artemisinin Intervention against COVID-19 had been cleared for patient enrollment in India. Artemisinin can target multiple viral threats, including COVID-19, by suppressing viral replication and clinical symptoms from viral infection. Viral replication cannot occur without TGF-β. Artemisinin, purified from a plant Artemisia annua, can inhibit TGF-β activity and can neutralize SARS-CoV-2 (COVID-19) in vitro at an EC50 of 0.45 ug/ml (Mateon’s test result at Utah State University), and a Safety Index of 140, which is better than remdesivir and chloroquine.
September 14, 2020 - The University of Pittsburgh School of Medicine scientists have isolated the smallest biological molecule to date that completely and specifically neutralizes the SARS-CoV-2 virus, which is the cause of COVID-19. This antibody component, which is 10 times smaller than a full-sized antibody, has been used to construct a drug—known as Ab8—for potential use as a therapeutic and prophylactic against SARS-CoV-2.
September 14, 2020 - InflaRx announced the start of the global Phase III part of its Phase II/III trial with IFX-1 in severe COVID-19 induced pneumonia with the initiation of the first clinical site in the Netherlands. In parallel, the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase III clinical trial in Germany.
September 10, 2020 - Corvus Pharmaceuticals, Inc. announced updated data from its ongoing Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19. The results demonstrated that all evaluable patients treated in the first two cohorts (0.3 and 1.0 mg dose of CPI-006) of the study produced significant titers of antibody to SARS-CoV-2 within seven days of receiving the treatment, with levels of antibody, including neutralizing antibodies, continually increasing out to 28 days. These patients were also discharged from the hospital with clinical improvement, and none experienced any drug-related safety issues. The study has completed enrollment in the third cohort (3.0 mg dose of CPI-006) of five patients, with the overall study expected to enroll up to 30 patients.
September 9, 2020 - Dr. Reddy's Laboratories announced the launch of Redyx, which is a potential treatment for COVID-19 pneumonia in India. The launch is part of the licensing agreement with Gilead Sciences, Inc. that grants Dr. Reddy’s rights to register, manufacture and sell Remdesivir in 127 countries, including India. In the USA, Remdesivir is now known as Veklury.
September 8, 2020 - RedHill Biopharma Ltd. announced that opaganib demonstrated potent inhibition of SARS-CoV-2, the virus that causes COVID-19, achieving complete blockage of viral replication in an in vitro model of human lung bronchial tissue. Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and anti-viral activity that targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance. Opaganib is currently being evaluated in global Phase 2/3 and U.S. Phase 2 clinical studies to treat severe COVID-19 pneumonia.
September 4, 2020 - California based Biomed Industries, Inc. announced the initiation of a Phase 3 study with 3,600 participants to evaluate the efficacy and safety of oral polio vaccine and NA-831™ for prophylaxis treatment of early onset of COVID-19.
September 3, 2020 - Mesoblast Limited announced that the independent Data Safety Monitoring Board (DSMB) recommended continuation of the Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome due to COVID-19 infection, following completion of the trial’s first interim analysis. The analysis was performed on the first 30% of randomized patients' total target with the DSMB.
September 2, 2020 - Investigational COVID-19 Convalescent Plasma. This document supersedes the guidance of the same title issued in April 2020 and updated in May 2020.
September 2, 2020 - Organicell Regenerative Medicine, Inc. announced the U.S. FDA granted emergency, expanded access approval to treat two mild to moderate COVID-19 disease patients and one “Long-Hauler” post-COVID-19 patient with Zofin.
August 2020 COVID-19 Disease Treatment News
August 31, 2020 - GlaxoSmithKline plc announced that the first patient was dosed in a phase 2/3 study with VIR-7831 (GSK4182136), a fully human anti-SARS-CoV-2 monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization. The COMET-ICE stud aims to enroll approximately 1,300 patients worldwide who have an early symptomatic infection and assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalization due to COVID-19 disease.
August 31, 2020 - Orpheris announced enrollment of the first patients in its multicenter Phase 2 PRANA clinical study of the HDT, OP-101, to treat hospitalized adults with severe COVID-19 disease. Investigators will conduct the studies at leading U.S. academic medical centers, including Johns Hopkins Hospital, Emory University, Loma Linda University Health, and The University of Texas Health Science Center at Houston.
August 28, 2020 - The U.S. FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection (ANDA 212571), indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting as well as the sedation of non-intubated patients before and/or during surgical and other procedures. The most common side effects of dexmedetomidine hydrochloride injection are hypotension (low blood pressure), bradycardia (slow heart rate), and dry mouth.
August 27, 2020 - Laurent Pharmaceuticals Inc. announced that it had received approval from the U.S. FDA to enroll U.S. patients in RESOLUTION, a multicentric Phase 2 randomized placebo-controlled trial testing once-a-day oral LAU-7b as a potential treatment against COVID-19 disease.
August 27, 2020 - RedHill Biopharma Ltd. announced that its U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe COVID-19 pneumonia has successfully passed the first scheduled independent Safety Monitoring Committee (SMC) review from the first 12 patients treated for at least 7-days, recommending that the study continues without change.
August 26, 2020 - HiFiBiO Therapeutics announced the submission of an Investigational New Drug application with the US FDA for a novel SARS-CoV-2 neutralizing antibody to treat COVID-19 disease patients. The highly differentiated antibody, HFB30132A, is an anti-SARS-CoV-2 recombinant antibody engineered with specific sequences identified from the B cells of a COVID-19 convalescent patient. The antibody also efficiently neutralizes a panel of mutated SARS-CoV-2 viral strains, including the well-described mutant D614G.
August 25, 2020 - AstraZeneca announced the first participants had been dosed in Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in the development prevention treatment of COVID-19 disease.
August 25, 2020 - Capricor Therapeutics announced that the U.S. FDA had accepted its investigational new drug application for a Phase 2 clinical trial of CAP-1002 in patients with COVID-19 disease. CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity.
August 24, 2020 - Innovation Pharmaceuticals announced it received additional data from a U.S. Regional Biocontainment Laboratory (RBL) based on ongoing in vitro testing supporting Brilacidin as a potential treatment SARS-CoV-2. In a new experiment at the RBL in a human lung epithelial cell line, Brilacidin, when directly incubated with the live (or wild type) virus, was shown to inhibit the virus by 50 percent (the IC50 value) at a mid-nanomolar concentration, while remaining non-cytotoxic to cells at high micromolar concentrations—establishing a SI for Brilacidin greater than 300 in this lung cell line. Additionally, this new testing in the human lung cell line showed Brilacidin’s IC90 value in the low micromolar range.
August 24, 2020 - Tiziana Life Sciences plc announced that the US Patent and Trademark Office had granted a patent for methods and use of a fully human monoclonal antibody (mAb; TZLS-501) that recognizes both IL-6 receptor (IL-6R) and IL-6 receptor complex with IL-6 (IL-6R/IL-6) for prophylactic and therapeutic intervention for human diseases. The grant of this additional patent on TZLS-501 is of particular significance for the potential treatment of COVID-19 and other pulmonary diseases such as acute respiratory distress syndrome.
August 21, 2020 - SAB Biotherapeutics announced the dosing of the first patient in its Phase 1b clinical trial evaluating the safety and pharmacological activity of SAB-185, a COVID-19 therapeutic. SAB-185 developed from a novel technology platform that leverages the native human immune response to offer a differentiated high-potency therapeutic option that potentially addresses virus mutations.
August 19, 2020 - Regeneron Pharmaceuticals and Roche - Genetech announced joining forces to develop, manufacture, and distribute REGN-COV2. Under this agreement, the overall capacity of REGN-COV2 is expected to increase by at least three and a half times.
August 19, 2020 - Sorrento Therapeutics announced that it is filing an investigational new drug application for COVI-GUARD (STI-1499) for hospitalized COVID-19 patients and has initiated manufacturing to produce 50,000 doses expected to be available by the end of 2020.
August 19, 2020 - India-based Dr. Reddy’s Laboratories Ltd. announced the launch of AVIGAN (Favipiravir) 200 mg Tablets in India.
August 18, 2020 - Elicio Therapeutics published preclinical studies of ELI-005, a protein subunit vaccine for COVID-19. Findings include a unique ability to elicit a high magnitude T Cell response to COVID-19 alongside potent neutralizing antibody induction. Since antibody responses to COVID-19 are short-lived, balanced responses, including potent and long-lived antiviral T cells, could result in durable protection following ELI-005 administration.
August 18, 2020 - Vanda Pharmaceuticals Inc. reported that interim analysis of the ODYSSEY phase 3 study showed that a 14-day tradipitant treatment accelerated clinical improvement by day 7 (HR=2.55, p=0.0375). Similar overall improvement and mortality rates were observed for the two treatment arms at day 28.
August 17, 2020 - CytoDyn Inc. announced it has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. Food and Drug Administration (FDA) and requested emergency use approval. Also, CytoDyn has sent its Top-line Report to the regulatory authorities in Mexico and hopes to obtain emergency use approval in the U.K., EMA in the European Union, and the Philippines' regulatory authorities.
August 13, 2020 - RedHill Biopharma Ltd. announced its Phase 2/3 clinical study evaluating opaganib in patients hospitalized with severe SARS-COV-2 infection and pneumonia. The study has received approvals in the UK, Russia, and Mexico and is set to enroll up to 270 patients in up to 40 clinical sites. The study is also under review in Brazil, Italy, and additional countries, with further expansion. In parallel, a Phase 2 study is ongoing in the U.S., evaluating opaganib in patients with severe COVID-19.
August 13, 2020 - TFF Pharmaceuticals announced that it has entered into a worldwide exclusive licensing agreement with UNION therapeutics A/S (UNION) for its TFF technology combined with niclosamide. TFF technology is used in oral and inhalation versions of niclosamide, potentially for COVID-19 disease and other niclosamide-based therapies.
August 11, 2020 - UC San Francisco scientists announced they had engineered a completely synthetic, production-ready molecule that straitjackets the crucial SARS-CoV-2 machinery that allows the virus to infect human cells. In an aerosol formulation called “AeroNabs,” these molecules could be self-administered with a nasal spray or inhaler.
August 11, 2020 - Romark announced the initiation of Phase 3 clinical trial of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) as a treatment for mild or moderate COVID-19. In cell cultures, the active ingredient in NT-300, nitazoxanide, inhibits replicating a broad range of respiratory viruses, including the SARS-CoV-2 coronavirus. Nitazoxanide has also been shown to inhibit replication of MERS, other coronaviruses, influenza viruses, rhinoviruses, parainfluenza viruses, RS, V, and other respiratory viruses in cell culture, studies. The broad-spectrum antiviral activity of nitazoxanide is attributed to its interference with human cellular pathways that the virus exploits to replicate, rather than a virus-targeted mechanism.
August 11, 2020 - SAB Biotherapeutics announced that the first participant had been dosed in its Phase 1 study evaluating the safety of SAB-185, a therapeutic candidate for COVID-19, in healthy volunteers. SAB-185, a highly potent polyclonal antibody therapeutic, could potentially treat ill patients and provide protective antibodies that could have significant value to protect the military, front-line responders, mission-critical staff, and high-risk populations against COVID-19 disease.
August 10, 2020 - A new therapy by GigaGen Inc., GIGA-2050, is a new class of drug called a recombinant hyperimmune, offers 100-fold higher potency than convalescent serum therapy. Announced on Mach 30, 2020, “GIGA-2050 is a mix of 12,500 different antibody sequences selected from 16 exceptional responders to COVID-19. 'There’s never been anything like that before, GigaGen CEO and co-founder David Johnson, Ph.D., told BioSpace.
August 7, 2020 - This FDA dashboard provides a snapshot of potential COVID-19 therapeutics development. Given the pandemic's urgent nature and the number of companies and researchers developing COVID-19 related therapies, the following numbers may change frequently. FDA will update these numbers monthly.
August 05, 2020 - Revive Therapeutics Ltd. announced the U.S. FDA approved the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. The clinical trial expects to engage up to 10 clinical trial sites in the USA and launch in September 2020.
August 4, 2020 - A new antibody treatment study in the US National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program launched. Patients admitted with COVID-19 disease at select hospitals in the USA may now volunteer to enroll in a clinical trial to test the safety and efficacy of a potential new treatment for the disease.
August 4, 2020 - ANA Therapeutics announced today that the U.S. FDA had cleared its investigational new drug application for ANA001 (niclosamide capsules) as a potential treatment for COVID-19 disease, making it the first U.S.-based company to conduct a human clinical trial to determine the efficacy of niclosamide to treat COVID-19. In pre-clinical research, niclosamide has been shown to stop the virus that causes COVID-19to to replicate and be more potent than remdesivir in the same assay. Furthermore, niclosamide has documented anti-inflammatory properties.
August 3, 2020 - Innovent Biologics, Inc. announced that the first patient had been successfully dosed in Phase 1 clinical trial (CIBI322A101) of the potentially first-in-class recombinant anti-CD47/PD-L1 bispecific antibody (IBI322) in China.
August 3, 2020 - Eli Lilly announced the initiation of BLAZE-2, a Phase 3 trial studying LY-CoV555 to prevent SARS-CoV-2 infection.
August 2, 2020 - NeuroRx, Inc. and Relief Therapeutics Holdings AG announced that RLF-100 (aviptadil) showed rapid recovery from respiratory failure in the most critically ill patients with COVID-19 disease. Simultaneously, independent researchers have reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes.
July 2020 COVID-19 Disease Treatment News
July 29, 2020 - Roche’s attempt to retool its rheumatoid arthritis drug Actemra/RoActemra to treat patients hospitalized with severe COVID-19-related pneumonia has failed in a late-stage trial.
July 27, 2020 - AI Therapeutics announced the start of Phase II clinical trial to treat newly diagnosed COVID-19 patients in collaboration with Yale University. The randomized, double-blind, placebo-controlled study (NCT04446377) will enroll up to 142 outpatients to evaluate the safety, tolerability, and efficacy of LAM-002A in reducing viral load in subjects with a confirmed COVID-19. LAM-002A is a first in class, highly selective PIKfyve kinase inhibitor1,2 that has demonstrated potent in vitro antiviral activity against several isolates of SARS-CoV-2.
July 27, 2020 - NeoImmuneTech, Inc. announced that it had received a study-may-proceed letter from the U.S. FDA for the second study evaluating NT-I7 (efineptakin alfa), a long-acting human IL-7, for the treatment in adult COVID-19 patients.
July 22, 2020 - RedHill Biopharma Ltd. announced that it had submitted a Clinical Trial Application with the Mexican Federal Committee for the Protection against Sanitary Risks and initiated CTA submission with the Brazilian Health Regulatory Agency for the Phase 2/3 clinical study evaluating opaganib (Yeliva, ABC294640)1 in patients hospitalized with severe SARS-CoV-2 infection and pneumonia.
July 21, 2020 - CytoDyn Inc., a biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced the patient safety data results from the Company’s over-enrolled COVID-19 Phase 2 trial for mild-to-moderate indications. Just 5 patients out of 56 (about 9%) reported serious adverse events; none were related to leronlimab.
July 21, 2020 - Moleculin Biotech, Inc. announced that the second round of independent laboratory testing had confirmed the antiviral activity of WP1122 against coronavirus.
July 21, 2020 - Selva Therapeutics, Inc. announced that the company had raised $3 million, with the financing proceeds to be used to advance SLV213 into clinical trials as an oral drug candidate to treat COVID-19. Also, SLV213cano is a treatment for multiple infectious diseases caused by other coronaviruses, such as SARS, Ebola viruses, Nipah virus, and Chagas disease, a parasitic disease spreading into the southern United States.
July 20, 2020 - The UK government announced it secured access to treatments containing COVID-19-neutralising antibodies from AstraZeneca to protect those who cannot receive vaccines, such as cancer and immunocompromised patients. The agreement with AstraZeneca will provide 1-million doses of a treatment containing COVID-19 neutralizing antibodies.
July 20, 2020 - Synairgen plc, which originated from research at the University of Southampton, announce positive results from its clinical trial of SNG001, its wholly-owned inhaled formulation of interferon beta hospitalized COVID-19 patients. The company stated that patients who received SNG001 had a 79% lower risk of developing severe COVID-19 disease than placebo. Patients who received SNG001 were more than twice as likely to recover from COVID-19 as those on placebo.
July 20, 2020 - Sorrento Therapeutics, Inc. received clearance from the U.S. FDA to initiate a Phase 2 trial of Abivertinib in patients with COVID-19 who have moderate to severe pulmonary symptoms. Abivertinib is a Novel Tyrosine Kinase Inhibitor with dual selective targeting of mutant forms of EGFR and BTK that has completed a registration trial (lung cancer) and been administered to over 600 patients worldwide.
July 18, 2020 - Patients with chronic lymphocytic leukemia who contract COVID-19 disease face more severe symptoms if they are older, though recent treatment with antileukemic agents appears to have a beneficial, rather than detrimental, effect on outcomes, a new study found. As for the impact of antileukemic therapies, the authors said a disproportionate percentage of their study population had been prescribed Bruton kinase inhibitors. Thus, they did not have sufficient data to compare BTK inhibitors' impact on other therapy types.
July 17, 2020 - Study: In patients hospitalized with Covid-19, dexamethasone use resulted in lower 28-day mortality among those receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support.
July 16, 2020 - Novartis announced a new initiative to help patients in low-income and lower-middle-income countries access affordable medicines to treat the major symptoms of COVID-19. The Novartis COVID-19 portfolio includes 15 medicines from its Sandoz division for gastrointestinal illness, acute respiratory symptoms, pneumonia as well as septic shock. The medicines were chosen based on clinical relevance and availability to ensure demand can be met globally.
July 16, 2020 - RedHill Biopharma Ltd. announced approval from the Ministry of Health of the Russian Federation for its Clinical Trial Authorization application for a Phase 2/3 study evaluating opaganib (Yeliva, ABC294640) in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia. The study was also recently approved in the UK, and a similar application is under review in Italy with plans to further expand the study to additional countries.
July 16, 2020 - Tonix Pharmaceuticals Holding Corp. announced it has entered into a research collaboration and option agreement with Columbia University. The research is designed to fill important gaps in understanding the detailed immune responses to COVID-19 disease and provide a foundation for targeting vaccines and therapeutics to appropriate precision medicine individuals.
July 15, 2020 - Oral petechial lesions observed in a small number of COVID-19 patients have some dermatologists curious if enanthem, in addition to skin rash exanthem, is a new symptom of the betacoronavirus.
July 15, 2020 - Bold Therapeutics announced vitro data showing that lead clinical-stage therapeutic, BOLD-100, successfully inhibits live SARS-CoV-2 (COVID-19) within a therapeutic range. This data is further supported by recent literature from independent researchers suggesting that GRP78, the primary target for BOLD-100, is an increasingly attractive antiviral target.
July 13, 2020 - Biocon Ltd. presented key insights into the pivotal study results that demonstrated its novel biologic, Itolizumab, significantly reduced mortality in moderate to severe ARDS (acute respiratory distress syndrome) patients hospitalized with COVID-19 in India. This led to the Drug Controller General of India approving this novel biologic therapy for restricted emergency use in India.
July 13, 2020 - Innovation Pharmaceuticals announced perspectives on the planned clinical trial testing of Brilacidin, administered intravenously (IV), for the treatment of COVID-19. Theepandemic's exigencies coupled with Brilacidin’s multiple therapeutic properties – its anti-viral SARS-CoV-2 activity, its anti-inflammatory potential to abate the COVID-19 associated cytokine storm, as well as its proven anti-bacterial properties – have the Company working vigilantly to advance Brilacidin into human trials against COVID-19 during fourth-quarter 2020.
July 13, 2020 - ExeGi Pharma LLC, a U.S.-based company, announced today the results of a 70-patient clinical trial evaluating a new biologic drug candidate in hospitalized COVID-19 patients. In short, all patients treated with standard therapy plus bacteriotherapy survived the COVID-19 illness, and none required invasive mechanical ventilation or ICU admission.
July 13, 2020 - BioSig Technologies, Inc. Its subsidiary, ViralClear Pharmaceuticals, Inc., announced adult patients' enrollment for its Phase II trial for merimepodib, a broad-spectrum, an orally administered antiviral drug candidate for the treatment of COVID-19, at four key trial sites. Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed a reduction in SARS-CoV-2 replication to undetectable levels.
July 12, 2020 - Junshi Biosciences announced the completion of study subjects enrollment in Phase I trial of SARS-CoV-2 neutralizing monoclonal antibody injection (Product Code: JS016), developed jointly with Institute of Microbiology, Chinese Academy of Sciences (IMCAS). JS016 is the first COVID-19 neutralizing antibody entering clinical trials in China. It also entered clinical trials in the USA during the second quarter of 2020.
July 11, 2020 - In this study of mechanically ventilated COVID-19 patients, tocilizumab was associated with lower mortality despite higher superinfection occurrence.
July 8, 2020 - A study confirms the potential effectiveness of Tocilizumab on COVID-19 — especially in critically ill patients — with a reliable comparison group that allows the determination of this treatment's potential clinical impact. Nevertheless, we suggest using Tocilizumab cautiously due to drug-related adverse events, remarkably transitory respiratory worsening, and bacterial infections.
July 8, 2020 - Recce Pharmaceuticals announced its RECCE 327 and RECCE 529 compounds were selected to be studied as treatments against COVID-19. RECCE® 327 is a broad-spectrum synthetic antibiotic formulated using synthetic polymer technology to treat blood infections and sepsis. RECCE® 529 is a new synthetic polymer formulation built upon the Company’s anti-infective expertise.
July 7, 2020 - Regeneron announced the Biomedical Advanced Research and Development Authority had awarded a $450 million contract to manufacture and supply REGN-COV2, Regeneron's investigational double-antibody cocktail that is currently in Phase 2/3 clinical trials for the treatment of COVID-19 disease, and in a Phase 3 trial, for the prevention of COVID-19 infection, which is caused by the SARS-CoV-2 virus.
July 7, 2020 - 7 Hills Pharma announced that preclinical studies reveal 7HP349, an oral integrin activator that promotes cell adhesion, significantly increases IgG binding antibodies with a vaccine targeting SARS-CoV-2 (COV2), the virus that causes COVID-19. The data also suggest 7HP349 can be used as an immunostimulant for any COVID-19 vaccine and has the potential not only to augment the vaccines’ effectiveness but also accelerate immune system response, allow for dose sparing and reduce or eliminate the need for boosters.
July 6, 2020 - Regeneron Pharmaceuticals, Inc. announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron's investigational double-antibody cocktail for the treatment and prevention of COVID-19 disease.
July 6, 2020 - CytoDyn Inc., a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced it had signed an exclusive Distribution and Supply Agreement with American Regent, Inc. for the distribution of leronlimab for the treatment of COVID-19 in the USA.
July 6, 2020 - CSL Behring announced that the first patient had been enrolled in its Phase 2 study to assess the safety and efficacy of CSL312 (garadacimab, FactorXIIa antagonist monoclonal antibody) to treat patients suffering from severe respiratory distress, a leading cause of death in patients with COVID-19 related pneumonia.
July 4, 2020 - The WHO announced the Solidarity Trial’s International SteeringCommittee's recommendation to discontinue hydroxychloroquine's clinical trial.
July 2, 2020 - Abivax SA announced that the first patient had been treated in its Phase 2b/3 study of ABX464 in COVID-19 patients at the University Hospital Center in Nice, France. The trial's main goal is to measure the potential of ABX464 to limit viral replication and the severe inflammation that leads to acute respiratory distress syndrome. Abivax has already received clearance for the study from the regulatory authorities in France and Germany and the UK, Italy, and Brazil and expects authorization to follow in Spain and additional Latin American countries with high infection rates, including Mexico, Chile Peru.
June COVID-19 Disease Treatment News
June 29, 2020 - NuvOx Pharma has received a “No Objection Letter” from Health Canada to proceed with a Phase IIa clinical trial of NanO2 in COVID-19 subjects with acute hypoxic respiratory failure (AHRF). Some patients with AHRF can progress to more severe acute respiratory distress syndrome (ARDS). ARDS, which is associated with lung inflammation leading to low blood oxygenation, is the major cause of death in COVID-19 patients.
June 29, 2020 - Altimmune, Inc. announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19 disease.
June 29, 2020 - Golden Biotechnology Corp. announced that the US FDA approved its investigational new drug application for a Phase II clinical trial of Antroquinonol (Hocena®) on COVID-19 patients in the USA. GoldenBiotech has also applied for the US BARDA CoronaWatch meeting.
June 26, 2020 - The governing Board of the California Institute for Regenerative Medicine (CIRM) awarded $750,000 to Dr. Xiaokui Zhang at Celularity to conduct a clinical trial for the treatment of COVID-19. This trial will use blood stem cells obtained from the placenta to generate natural killer cells, a white blood cell that is a vital part of the immune system, and administer them to patients with COVID-19.
June 25, 2020 - Theravance Biopharma, Inc. announced that the first COVID-19 patient had been dosed in a Phase 2 study of TD-0903. TD-0903 is a lung-selective, nebulized Janus kinase inhibitor in development for the potential treatment of hospitalized patients with Acute Lung Injury caused by COVID-19. The Company believes TD-0903 can inhibit the cytokine storm associated with ALI and prevent Acute Respiratory Distress Syndrome progression.
June 25, 2020 - EMD Serono announced the U.S. FDA had cleared its investigational new drug application for M5049 to treat patients with Covid-19 pneumonia. M5049 is a potentially first-in-class small molecule that blocks the activation of Toll-like receptor (TLR)7 and TLR8, two innate immune sensors that detect single-stranded (ss) RNA from viruses, such as SARS-CoV-2. Activation of TLR7/8 leads to immune cell activation and inflammation, which, when not properly controlled, can cause severe immunopathology.
June 23, 2020 - Mateon Therapeutics has selected IQVIA to manage C001, a Phase 2 randomized, controlled, multi-center clinical study of OT-101, a wide spectrum anti-viral agent demonstrated activity against SARS-CoV-2 in the nanomolar range comparable to remdesivir, however, with a higher safety index. By targeting the host protein, TGF-β, OT-101 avoids resistance mutations that could render vaccines and/or therapeutics against the viral protein(s) ineffective.
June 22, 2020 - A non-peer-reviewed study found the use of dexamethasone reduced fatalities by 1/3 in patients receiving invasive mechanical ventilation, by 1/5 in patients receiving oxygen without invasive mechanical ventilation.
June 19, 2020 - Ridgeback Biotherapeutics announced the launch of two Phase 2 clinical trials to test the efficacy of EIDD-2801 as an anti-viral treatment for COVID-19.
June 19, 2020 - Veru Inc. announced that it had enrolled the first patient in its Phase 2 clinical trial of VERU-111, a novel microtubule depolymerization drug to combat COVID-19, the global pandemic disease caused by the coronavirus SARS-CoV-2.
June 17, 2020 - Innovation Pharmaceuticals' Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and by 97 percent, compared to control.
June 17, 2020 - PTC Therapeutics, Inc. announced that the U.S. FDA had authorized the initiation of a Phase 2/3 trial to investigate PTC299, a dihydroorotate dehydrogenase inhibitor, as a potential treatment for COVID-19 disease. PTC299 is an oral investigational drug with a novel dual mechanism of action.
June 16, 2020 - Low-cost dexamethasone reduces death by up to one third in hospitalized patients with severe respiratory complications of COVID-19 disease.
June 15, 2020 - The US FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.
June 15, 2020 - Eli Lilly and Company announced that the first patient had been enrolled in Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor, in hospitalized adults with COVID-19. Baricitinib, marketed as OLUMIANT®, is approved in 70 countries to treat adults with moderately to severely active rheumatoid arthritis. A 2-mg is indicated to treat adult patients moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.
June 15, 2020 - aTyr Pharma, Inc. announced that it had dosed the first patient in a Phase 2 study evaluating its lead therapeutic candidate, ATYR1923, in COVID-19 patients with severe respiratory complications. The study is expected to enroll 30 patients at up to 10 centers in the USA, and the company expects to have the majority of centers enrolling within the coming weeks.
June 14, 2020 - OncoImmune, Inc. announced it reached an important milestone in its Phase III clinical trial testing the safety and clinical efficacy of CD24Fc for severe and critical COVID-19 patients (SAC-COVID) on June 9, 2020. The first 70 patients have been randomized and received either CD24Fc or placebo as the treatment for severe COVID-19. After reviewing the safety data, the Institutional Review Board has approved continuing enrollment while interim analysis occurs.
June 11, 2020 - Regeneron Pharmaceuticals announced the initiation of the first clinical trial of REGN-COV2, it's investigational dual antibody cocktail to prevent and treat COVID-19 disease. The concept that drug cocktails can prevent viral escape has previously been demonstrated for traditional antiviral drugs used to treat HIV and other viruses.
June 9, 2020 – Immunic, Inc. announced receipt of regulatory allowance from the U.S. FDA to initiate its phase 2, CALVID-1 clinical trial of IMU-838, the company’s selective oral DHODH inhibitor, in coronavirus disease 2019 (COVID-19) at centers in the United States.
June 9, 2020 – After encouraging preliminary results in the treatment of critically-ill COVID-19 patients at a military hospital in the United States and 14 other hospitals in Europe, the US Department of Defense has selected the Seraph®100 Microbind® Affinity Blood Filter (Seraph 100) as one of its main interventions in a pivotal, US-based randomized controlled trial.
June 8, 2020 – RELIEF THERAPEUTICS Holding AG and its U.S. partner, NeuroRx, Inc., announced that the Phase 2/3 clinical trial evaluating RLF-100 as a treatment for Critical COVID-19 with Respiratory Failure had been expanded to include patients receiving high-flow oxygen and noninvasive ventilation (CPAP), in addition to those on ventilators. RLF-100 (Aviptadil) is a patented formulation of synthetic human Vasoactive Intestinal Peptide, which has been granted Orphan Drug Designation by the US FDA in Acute Respiratory Distress Syndrome and chronic lung diseases.
June 8, 2020 - Eli Lilly and Company announced its partner Junshi Biosciences had dosed the first healthy volunteer in a study of a potent neutralizing antibody treatment designed to fight COVID-19. The investigational medicine, referred to as JS016, is being co-developed by Junshi Biosciences and Lilly, with Junshi Biosciences leading development in greater China.
June 7, 2020 - Junshi Biosciences announced that the first healthy volunteer had been dosed in Phase I clinical study of JS016 at Huashan Hospital Affiliated to Fudan University in China. JS016 is the first SARS-CoV-2 neutralizing antibody to enter clinical trials in China. Junshi and Eli Lilly and Company are collaborating to co-develop JS016 globally, with Junshi leading clinical development in China and Lilly leading clinical development in the rest of the world.
June 5, 2020 - NIH study: Blocking the Bruton Tyrosine Kinase Protein May Help Severe COVID-19 Patients. Researchers observed that the off-label use of the cancer drug acalabrutinib, a BTK inhibitor that is approved to treat several blood cancers, was associated with reduced respiratory distress and reduced overactive immune response in the treated patients.
June 5, 2020 - AbbVie, Harbour BioMed (HBM), Utrecht University (UU), and Erasmus Medical Center (EMC) today announced they have entered into a collaboration to develop novel antibody therapeutics to prevent and treat COVID-19, the pandemic respiratory disease caused by the SARS-CoV-2 virus. The collaboration focuses on advancing the fully human, neutralizing antibody 47D11 discovered by UU, EMC, and HBM and recently reported in Nature Communications.
June 5, 2020 - The University of Pennsylvania has launched a phase 1 open-label, single-arm trial that will assess the safety and efficacy of convalescent plasma in severely ill, mechanically ventilated participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women. A total of 50 eligible participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
June 04, 2020 - Algernon Pharmaceuticals Inc. announced that it had received clearance from the U.S. FDA for its recently submitted Investigational New Drug application for its planned multinational Phase 2b/3 study re-purposed drug NP-120 (Ifenprodil) as a potential treatment for patients with COVID-19. Ifenprodil is an NMDA receptor antagonist.
June 3, 2020 - The World Health Organization (WHO)leader announced they would resume testing an experimental COVID-19 disease treatment, Plaquenil (Hydroxychloroquine). This drug is FDA-approved to prevent or treat malaria caused by mosquito bites. So far, more than 3,500 patients have been recruited in 35 countries to participate in this clinical trial.
June 3, 2020 - A phase 4 clinical trial has launched in the UK testing the impact when treating COVID-19 disease patients with ibuprofen, often known as Advil. The LIBRATE study at Kings College, last updated on May 28, 2020, aims to evaluate the reduction in severity and progression of lung injury with 3-doses of lipid ibuprofen in 230 patients SARS-CoV-2 infections.
June 3, 2020 - Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment did not significantly improve the time to clinical improvement within 28 days. However, the trial was terminated early and may have been underpowered to detect a clinically important difference and reported JAMA's study.
June 1, 2020 - Eli Lilly announced patients had been dosed in the world's first study of a potential antibody treatment designed to fight COVID-19 disease. This investigational medicine, referred to as LY-CoV555, is the first to emerge from Lilly and AbCellera to create antibody therapies to prevent and treat COVID-19.
June 1, 2020 - Avifavir, a Favipiravir-based drug, has received a temporary registration certificate from the Ministry of Health of the Russian Federation. Avifavir is Russia’s first COVID-19 drug and has shown high efficacy in treating patients diagnosed with COVID-19 disease during human clinical trials.
June 1, 2020 - Gilead announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia on June 1, 2020. This study demonstrated that patients in the 5-day remdesivir treatment group were 65% more likely to have clinical improvement at Day 11 than those in the standard care group.
June 1, 2020 - OPKO Health, Inc. announced that the U.S. FDA had authorized OPKO to undertake a Phase 2 trial with RAYALDEE® to treat patients with mild-to-moderate COVID-19.
May COVID-19 Disease Treatment News
May 29, 2020 - A new study reported the off-label use of Anakinra reduced both needs for invasive mechanical ventilation in the ICU and mortality among patients with severe forms of COVID-19 without serious side-effects. Confirmation of efficacy will require controlled trials.
May 28, 2020 - Roche announced the initiation of a global phase III, randomized, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra, plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.
May 25, 2020 - Algernon Pharmaceuticals Inc. announced that it had submitted an Investigational New Drug application with the U.S. FDA for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120 (Ifenprodil), an NMDA receptor antagonist, 20 mg tablets, as a potential treatment for patients with COVID-19 disease.
May 23, 2020 - The data and safety monitoring board for the phase 3 Clinical Trial NCT04280705 recommended early unblinding of the results based on findings from an analysis that showed a shortened time to recover the remdesivir group.
May 22, 2020 - The Indian Council of Medical Research, the country of India’s apex body in the field, has found that consuming the drug hydroxychloroquine reduces the chances of getting infected with Covid-19 disease.
May 22, 2020 - Cuba credits two drugs with slashing coronavirus death toll. One is itolizumab, a monoclonal antibody produced in Cuba and elsewhere. The other is a peptide that Cuba says its biotech industry discovered and tested for rheumatoid arthritis in Phase II clinical trials.
May 22, 2020 - Fujifilm Corp. said it is on course to supply the anti-influenza drug Avigan for 2 million COVID-19 patients by March 2021.
May 21, 2020 – CalciMedica Inc. announced that it had received guidance from the U.S. FDA regarding the Company’s ongoing study of Auxora™ (formerly called CM4620-IE) in patients with COVID-19 pneumonia.
May 20, 2020 - Aldeyra Therapeutics, Inc. announced the planned advancement of the investigational new HSP90 inhibitor ADX-1612 to clinical testing for COVID-19 disease. It provided an update on ADX-629, a novel investigational RASP inhibitor in development for COVID-19 and other inflammatory diseases.
May 20, 2020 - Atea announced the U.S. FDA had given the go-ahead for its investigational new drug (IND) application for AT-527 for adults hospitalized with moderate COVID-19. AT-527 is a novel, oral, purine nucleotide prodrug, a direct-acting antiviral that inhibits the RNA polymerase enzyme. The Phase II trial is scheduled to begin soon.
May 20, 2020 - BioSig Technologies, Inc. Its subsidiary, ViralClear Pharmaceuticals, Inc., announced the closing of a $10.8 million common stock financing. ViralClear plans to use this offering's proceeds for the development, including phase II human clinical trials, of its product candidate merimepodib, a broad-spectrum antiviral agent.
May 19, 2020 - Innovation Pharmaceuticals announced today that its anti-SARS-CoV-2 (COVID-19) drug candidate, Brilacidin, in an in vitro experiment using VERO cells, reduced the viral titer (load) of SARS-CoV-2 by 75 percent after only 1 hour of preincubation before infection at a concentration of 10μM as compared to vehicle control.
May 19, 2020 - Scientists in China believe a new drug can stop pandemic 'without a vaccine.' Xie said his team had been working "day and night" searching for the antibody. "Our expertise is single-cell genomics rather than immunology or virology. When we realized that the single-cell genomic approach could effectively find the neutralizing antibody, we were thrilled."
May 18, 2020 - BioSig Technologies, Inc. announced that the U.S. FDA had completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it might proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 hospitalized and either require supplemental oxygen or are on non-invasive ventilation high flow oxygen devices.
May 18, 2020 - Vir Biotechnology, Inc. announced the publication of research findings from the company’s efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. Additionally, Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831, and VIR-7832, in collaboration with GlaxoSmithKline.
May 18, 2020 - CytoDyn Inc. announced it would be submitting a protocol to the U.S. FDA for a factorial design trial to compare the effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19 disease. CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S., and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the USA.
May 15, 2020 - Sorrento Therapeutics, Inc. announced that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in vitro virus infection experiment at a deficient antibody concentration. As recently announced, Sorrento aims to generate an antibody cocktail product that would act as a "protective shield" against SARS-CoV-2 coronavirus infection and remain effective even if virus mutations render a single antibody therapy less effective over time.
May 14, 2020 - RESTEM, a leading cell-based therapeutics company, announced it had received approval from the U.S. FDA for a 60-patient Phase I/IIa study using the umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. The study will be the first of its kind in the USA.
May 14, 2020 - Abivax SA announced that ABX464 inhibits replication of SARS-CoV-2 in an in vitro reconstituted human respiratory epithelium model, as assessed by Transepithelial electrical resistance and RTqPCR. ABX464 has already been shown to be an effective drug candidate in severe inflammatory disease, ulcerative colitis.
May 11, 2020 - Bellerophon Therapeutics, Inc. announced that the U.S. FDA accepted its Investigational New Drug application, allowing the Company to initiate a Phase 3 study of INOpulse® inhaled nitric oxide therapy in up to 500 patients infected with COVID-19.
May 8, 2020 - The Lancet: New triple antiviral drug combination shows early promise for treating COVID-19 in phase 2 randomized trial. Early triple antiviral therapy was safe and superior to lopinavir-ritonavir alone to alleviate symptoms and shorten the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19.
May 8, 2020 - A new, non-peer-reviewed study found Famotidine, which is known as Pepcid, was associated with reduced risk of intubation or a fatality in hospitalized COVID-19 patients. The research said 'patients who took this heartburn medicine while hospitalized for COVID-19 were more than 2x as likely to survive the infection.
May 8, 2020 - Sorrento Therapeutics, Inc. and Mount Sinai Health System have agreed to join forces to investigate and develop an antibody cocktail (COVI-SHIELD™) potentially treat COVID-19.
May 8, 2020 - Arch Biopartners Inc. announced it had received a No Objection Letter from Health Canada to conduct a Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation experienced by patients with COVID-19.
May 8, 2020 - PluristemTherapeutics Inc. announced today that the U.S. FDA had cleared the Company’s IND application for a Phase II study of its PLX cells in treating severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome.
May 4, 2020 - Junshi Biosciences and Eli Lilly and Company announced they have agreed to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus.
May 4, 2020 - Vir Biotechnology, Inc. and Alnylam Pharmaceuticals, Inc. announced that they had selected a development candidate for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome. The companies plan to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19.
May 4, 2020 - CytoDyn Inc., a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the Company is expecting enrollment completion for its 75 patient, Phase 2 double-blinded, placebo-controlled, randomized study by the end of this month.
May 1, 2020 - The U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
May 1, 2020 - A Phase 2 multiple-dose phase 2 study of the PUL-042 inhalation solution reduces the severity of COVID-19 disease in adults who are positive for SARS-CoV-2 infection. This study is sponsored by Pulmotect, Inc., which has collaborated with MD Anderson and Texas A&M University researchers.
April COVID-19 Disease Treatment News
April 30, 2020 - Glenmark Pharmaceuticals announced that it had received approval from the Drug Controller General of India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 disease patients. The product is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a Fujifilm Corporation subsidiary.
April 29, 2020 - Gilead reported topline results from the open-label, Phase 3 SIMPLE trial. The time to clinical improvement with Remdesivir for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14.
April 28, 2020 - Innate Pharma SA announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab (IPH5401), in COVID-19 disease patients with severe pneumonia.
April 28, 2020 - PharmaMar announced the start of the APLICOV-PC clinical trial with Aplidin® (plitidepsin) to treat patients with COVID-19, authorized by the Spanish Medicines and Healthcare Products Agency.
April 27, 2020 - Tocilizumab was reported to improve patients' clinical outcomes with moderate or severe COVID-19 pneumonia. Patients were selected based on being hospitalized for COVID-19 moderate or severe pneumonia, not requiring intensive care upon admission. The primary composite outcome was the need for ventilation (non-invasive or mechanical) or death at day 14. A total of 129 patients were randomized: 65 to the standard of care + tocilizumab and 64 to the standard of care alone.
April 27, 2020 - Mateon Therapeutics Inc. announced today it had submitted an IND application to the FDA to study its investigational drug, OT-101, to treat the COVID-19 pandemic. The proposed randomized, double-blind, placebo-controlled Phase 2 study is intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with COVID-19 and pneumonia in the US. OT-101 is a potent inhibitor of SAR-CoV2 replication with efficacy and safety index on par or superior to Remdesivir- a Gilead’s drug. Unlike Remdesivir- OT-101 targets the virus replication and the often lethal clinical sequelae of COVID-19, including pneumonia and fibrosis.
April 27, 2020 - Innovation Pharmaceuticals announced the Company had been informed by researchers at the U.S. Regional Biocontainment Laboratory (RBL) that continued coronavirus (COVID-19) testing Brilacidin, the Company’s defensin-mimetic drug candidate, is scheduled to begin the week of May 4th. Concurrently, the Company is prioritizing Brilacidin’s clinical development by taking steps to advance Brilacidin testing in human trials rapidly. The initial testing at the RBL showed that Brilacidin had antiviral activity against SARS-CoV-2 in Vero cells, a screening assay using a monkey epithelial cell-line.
April 27, 2020 - Regeneron Pharmaceuticals Inc. and Sanofi SA announced they would discontinue part of a clinical study exploring whether their arthritis therapy, Kevzara, could treat certain hospitalized COVID-19 patients.
April 27, 2020 - Aytu BioScience, Inc. announced today that it had signed an agreement with Sterling Medical Devices to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus. Last week, the company announced that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to develop a novel endotracheal device to rapidly combat coronavirus.
April 27, 2020 - CNN reported hospitals in New York are giving COVID-19 patients heartburn medicine. Preliminary results of the clinical trial of famotidine, the active ingredient in Pepcid, could come out in the next few weeks, said Dr. Kevin Tracey, president of Feinstein Institutes for Medical Research at Northwell Health. So far, 187 patients have enrolled in the clinical trial, and Northwell eventually hopes to enroll 1,200, he said.
April 24, 2020, the FDA issued a caution against hydroxychloroquine or chloroquine for COVID-19 disease treatment outside of a hospital setting or clinical trial due to the risk of heart rhythm problems.
April 23, 2020 - Eli Lilly reported the company agreed with the NIAID to study baricitinib as an arm in NIAID's Adaptive COVID-19 Treatment Phase 3 Trial. The company also announced that it would advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome. The company agreed with AbCellera to co-develop antibody products for the potential treatment and prevention of COVID-19.
April 22, 2020 - “The guideline for diagnosis and treatment of COVID-19 issued by WHO and National Health Commission of the People's Republic of China suggests that ribavirin, lopinavir/ritonavir antiviral therapy should be used in COVID-19 patients,” the researchers wrote in the Journal of Internal Medicine.
April 21, 2020 - aTyr Pharma, Inc. announced that the U.S. FDA had accepted its Investigational New Drug (IND) application to evaluate its lead therapeutic candidate, ATYR1923, in a Phase 2 study in COVID-19 patients with severe respiratory complications. ATYR1923 has been shown pre-clinically to downregulate T-cell responses, which dampens the inflammatory cytokine and chemokine signaling implicated in these severe COVID-19 cases. ATYR1923 has also been shown to improve lung function and reduce inflammation and fibrosis in multiple animal models of immune-mediated acute lung injury, the company said.
April 21, 2020 - Vivacelle Bio, Inc., announced it would make VBI-S available for use in COVID-19 disease patients. Seventy percent of deaths of COVID-19 patients are due to septic shock. While the intravenous infusion of VBI-S has demonstrated encouraging preliminary results in a phase IIa clinical study, VBI-S remains an experimental drug.
April 20, 2020 - Innovation Pharmaceuticals is pleased to report that based on molecular screening of 11,552 compounds comprising already FDA-approved drugs and those in clinical testing, Brilacidin, the Company’s defensin-mimetic drug candidate targeting COVID-19, was identified as one of the most promising potential inhibitors of SARS-CoV-2, the novel coronavirus responsible for COVID-19. Brilacidin has shown, in cellular assays, direct antiviral activity against SARS-CoV-2 and has been selected for further antiviral testing by researchers at the U.S. Regional Biocontainment Laboratory (RBL) who conducted these initial tests.
April 19, 2020 - The WHO concluded ‘at present, there is no evidence of severe adverse events, acute health care utilization, long-term survival, or quality of life in patients with COVID-19 due to the use of NSAIDs.
April 13, 2020 - Ridgeback Biotherapeutics announced clearance by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for an orally available antiviral compound, EIDD-2801, begin human testing as a treatment for COVID-19 disease. EIDD-2801 is an orally bioavailable form of a highly potent ribonucleoside analog that inhibits the replication of multiple RNA viruses, including SARS-CoV-2, the causative agent COVID-19. In animal studies of two distinct coronaviruses (SARS-CoV1 and MERS), EIDD-2801 has been shown to improve pulmonary function, decrease body weight loss,s and reduce the number of viruses in the lung.
April 11, 2020 - A new study was performed by researchers at IHU Méditerranée Infection, Marseille, France, of the 1,061 coronavirus infected patients treated entirely with hydroxychloroquine and azithromycin, mortality is around 0.5%, and that the cure rate is extremely high.
April 10, 2020 - Gilead Sciences announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. The majority of patients in this international cohort demonstrated clinical improvement, and no new safety signals were identified with remdesivir treatment. This analysis's detailed results were published today in The New England Journal of Medicine.
April 9, 2020 - FirstWave Bio, Inc., announced plans to initiate a Phase 2a/2b study with FW-1022, a proprietary oral formulation of Niclosamide, in patients with COVID-19, beginning in mid-2020. With insights emerging into the gastrointestinal (GI) tract's crucial role in COVID-19 severity and transmission.
April 9, 2020 - Pfizer confirmed a lead compound and analogs are potent inhibitors of the SARS-CoV-2 3C-like (3CL) protease, based on the results of initial screening assays. Also, preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2. Consequently, Pfizer will perform pre-clinical confirmatory studies, including further anti-viral profiling and assessing the lead molecule's suitability for IV administration clinically. In parallel, the company is also investing in materials that will accelerate the start of a potential clinical study of the lead molecule to third-quarter 2020, three or more months in advance of earlier estimates, subject to positive completion of pre-clinical confirmatory studies.
April 8, 2020 - CSL Behring and SAB Biotherapeutics announced their partnership to combat the coronavirus pandemic with the rapid development of SAB-185, a COVID-19 therapeutic candidate on track for clinical evaluation by early summer. The therapeutic candidate, SAB-185, is generated from SAB’s proprietary DiversitAb™ platform producing large volumes of human polyclonal antibodies targeted specifically to SARS-CoV-2 coronavirus that causes COVID-19 disease.
April 7, 2020 - CytoDyn Inc. announced today that Novant Health is initiating patient enrollment in CytoDyn’s Phase 2 randomized clinical trial with leronlimab (PRO 140), a CCR5 antagonist, for COVID-19 patients with mild-to-moderate indications. Novant Health is the first site in the southeastern United States to initiate this Phase 2 trial. CytoDyn is also initiating a Phase 2b/3 study for severely ill COVID-19 patients. Patients enrolled in this trial are expected to be administered leronlimab for two weeks. The primary endpoint is the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis of the data from 50 patients.
April 7, 2020 - Alexion Pharmaceuticals is set to enter the COVID-19 drug development race in the next few days via a single-arm, 100-patient Phase II trial investigating already approved Soliris (eculizumab), according to a source familiar with the trial. If this Phase II trial delivers a positive risk-benefit ratio, it would then pave the way for a 300-patient, randomized trial that would start shortly after.
April 7, 2020 - Karyopharm Therapeutics Inc. announced plans to initiate a randomized clinical trial for low-dose, oral selinexor in hospitalized patients with severe COVID-19. Selinexor, marketed as XPOVIO®, is currently approved at higher doses by the FDA to treat patients with relapsed or refractory multiple myeloma. Selinexor is an oral, selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1. In addition to its cancer roles, XPO1 also facilitates the transport of several viral proteins from the host cell's nucleus to the cytoplasm1. It amplifies the activities of pro-inflammatory transcription factors.
April 6, 2020 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they had signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will also utilize Vir’s CRISPR screening and machine learning approach to identify cellular targets whose inhibition can prevent viral infection.
April 6, 2020 - Ridgeback Biotherapeutics LP and Drug Innovations at Emory, LLC announced that the U.S. FDA had approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), LLC, wholly owned by Emory University, for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback. The FDA's action allows Ridgeback to initiate human clinical testing of EIDD-2801 in the USA.
April 6, 2020 – Biotest, BPL, LFB, and Octapharma have joined an alliance formed by CSL Behring and Takeda Pharmaceutical to develop a potential plasma-derived therapy for treating COVID-19. The alliance will begin the investigational development of one unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19 disease.
April 6, 2020 - RedHill Biopharma Ltd. announced that it had received authorization from the Italian National Institute for Infectious Diseases and Central Italian Ethics Committee for an expanded access program allowing immediate, compassionate use of its investigational drug, opaganib (Yeliva®, ABC294640), in Italy, for patients with confirmed COVID-19 infection with life-threatening clinical manifestations. Approximately 160 patients are planned to be treated in three major hospitals in northern Italy, one of the pandemic's current major epicenters.
April 6, 2020 - Researchers at The University of Texas at Austin are now using new drug delivery formulation technologies to increase niclosamide’s absorption into the body, designing the drug so that it can be inhaled directly into the lungs, which could prove effective at treating and preventing serious COVID-19 virus symptoms in patients.
April 03, 2020 - The FDA is taking the lead role in a national effort to facilitate the development of and access to two investigational therapies derived from human blood. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus. The products can be administered to individuals diagnosed with COVID-19.
April 2, 2020 - Incyte announced it is working with the U.S. FDA to initiate a Phase 3 clinical trial (RUXCOVID) to evaluate the efficacy and safety of ruxolitinib (Jakafi®) plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19 associated cytokine storm. The collaborative study will be sponsored by Incyte in the United States and Novartis outside of the United States.
April 02, 2020 - Emergent BioSolutions Inc. announced that it has entered into a formal partnership with the U.S. government to expedite the development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.
April 1, 2020 - Innovation Pharmaceuticals announced it had received data supporting Brilacidin’s direct inhibition of SARS-CoV-2, the novel coronavirus responsible for COVID-19.
March COVID-19 Disease Treatment News
March 31, 2020 - FUJIFILM Toyama Chemical Co., Ltd. announced today the initiation of phase III clinical trial to evaluate the safety and efficacy of influenza antiviral drug “Avigan Tablet” (generic name: favipiravir) in Japan for patients of COVID-19 disease, a respiratory infection caused by the novel Coronavirus SARS-CoV-2.
March 30, 2020 - BARDA and Johnson & Johnson have expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The Company aims to identify potential treatments against the novel coronavirus. J&J and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven) in Belgium.
March 30, 2020 - CytoDyn Inc. announced an additional 3 critically ill COVID-19 disease patients had been treated with leronlimab. These additional patients increase by 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug granted by the U.S. FDA.
March 30, 2020 - Bellerophon Therapeutics, Inc. announced that expanded access treatment with the INOpulse® inhaled nitric oxide system (iNO) was initiated for the 1st time in a patient with a diagnosis of the novel coronavirus disease (COVID-19) at the University of Miami School of Medicine. The treatment follows the U.S. FDA's recent decision to grant emergency expanded access that allows INOpulse to immediately be used to treat COVID-19 under their physician's care and supervision.
March 29, 2020 - Novartis Chief Executive Vas Narasimhan said his Sandoz generics unit's malaria, lupus, and arthritis drug hydroxychloroquine is the company's biggest hope against the coronavirus, Swiss newspaper SonntagsZeitung. On March 26th, Novartis has pledged to donate 130 million doses and supports clinical trials needed before the medicine. U.S. President Donald Trump also has been promoting and can be approved for use against the coronavirus.
March 25, 2020 - Vir Biotechnology, Inc. announced that it had identified multiple human monoclonal antibody (mAb) development candidates that neutralize SARS-CoV-2, the virus responsible for COVID-19. This antibody's ability to neutralize the SARS-CoV-2 live virus has been confirmed in two separate laboratories. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (also known as SARS), indicating that it is highly conserved. Vir believes that this epitope's conservation will make it more difficult to escape mutants develop.
March 24, 2020 - Aldeyra Therapeutics, Inc. announced that it would begin screening its library of novel reactive aldehyde species (RASP) inhibitors, including ADX-629 and reproxalap, for potential anti-inflammatory and antiviral activity in the treatment of COVID-19 infection.
March 23, 2020 – AlloVir announced expanding its research and development collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus-specific T-cell therapies to combat SARS-CoV-2, the virus that causes COVID-19.
March 22, 2020 - Gilead Sciences stated access to Remdesivir outside clinical trials. Gilead is currently transitioning from individual compassionate use requests to expanded access programs to streamline the emergency access process. This approach will accelerate access to remdesivir for severely ill patients and enable data collection from all participating patients. These programs are currently under rapid development in conjunction with national regulatory authorities worldwide and may vary by region based on local laws and regulations.
March 20, 2020 - Teva Pharmaceutical announced the immediate donation of more than 6 million doses of hydroxychloroquine sulfate tablets through wholesalers to hospitals across the U.S. to meet the urgent demand for the medicine as an investigational target to treat COVID-19 disease. Although the product is not currently approved for use in the treatment of COVID-19, it is approved by the U.S. FDA to treat malaria, lupus erythematosus, and rheumatoid arthritis.
March 19, 2020 - Roche announced they were working with the US FDA to initiate a Phase III clinical trial in collaboration with BARDA, a part of the US Health HHS, to evaluate the safety and efficacy of Actemra®/RoActemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.
March 17, 2020 - Regeneron Pharmaceuticals announced scientists have now isolated hundreds of virus-neutralizing, fully-human antibodies from the company's VelocImmune® mice, which have been genetically-modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19 to maximize the pool of potentially potent antibodies. From this large pool of candidates, Regeneron will select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities.
March 16, 2020 - Regeneron Pharmaceuticals, Inc. and Sanofi announced they had started a clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19 infection. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of severely or critically ill patients with COVID-19. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody.
March 13, 2020 - Enanta Pharmaceuticals, Inc. announced that it had initiated a program to discover direct-acting antiviral drug candidates to treat patients infected with the novel coronavirus SARS-CoV-2 causes COVID-19 disease in humans.
March 10, 2020 - An article published in The Guardian said 'the USA, China, and Italy are already using Remdesivir on a compassionate basis to treat small numbers of patients with severe Covid-19 disease.'
March 9, 2020 - The Bill & Melinda Gates Foundation, Wellcome, and Mastercard announced the intent to provide seed-funding up to $125 million to speed-up the response to the COVID-19 disease epidemic by launching the COVID-19 Therapeutics Accelerator.
March 6, 2020 - Innovation Pharmaceuticals announced a 2nd Material Transfer Agreement to provide Brilacidin to a major U.S. university for analysis. Brilacidin is one of the few drugs targeting COVID-19 disease that has been tested in human trials for other clinical indications, providing an established safety and efficacy profile, developed both as an intravenous medicine and as a possible vaccine.
March 5, 2020 - A study published in Cell by German researchers identified a cellular protein important for entering the SARS-CoV-2 virus into lung cells. "Our results show that SARS-CoV-2 requires the protease TMPRSS2, which is present in the human body, to enter cells," says Stefan Pöhlmann, head of the Infection Biology Unit at the German Primate Center. "This protease is a potential target for therapeutic intervention."
March 4, 2020 - Takeda Pharmaceutical announced that it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals infected with COVID-19 disease, while also studying whether Takeda’s currently marketed and pipeline products may be effective treatments for infected patients.
March 3, 2020 - Regeneron CEO Leonard Schleifer told CNBC that the pharmaceutical company hopes to have its coronavirus treatment produced and ready for human testing, possibly by August 2020. Understanding the urgency with which the coronavirus needs to be confronted, Schleifer said Regeneron would be pursuing clinical trials and drug manufacturing at once
March 2, 2020 - Innovation Pharmaceuticals offers a scientific rationale and clinical development perspective for Brilacidin, the Company’s defensin mimetic drug candidate, as a potential novel coronavirus (COVID-19) treatment. Notably, Brilacidin is one of the few drugs targeting COVID-19 that has been tested in humans in Phase 2 clinical trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to help confront the emerging worldwide coronavirus crisis rapidly.
March 02, 2020 - Mateon Therapeutics, Inc. announced a new division will be dedicated to the development of rapid responses to the current COVID-19 virus outbreak, as well as future virus outbreaks, and will be led by Dr. Cyril Empig, who has been appointed Head of the Rapid Antiviral Response Program.
February COVID-19 Disease Treatment News
February 27, 2020 - Innovation Pharmaceuticals announced the signing of a Material Transfer Agreement with one of the country’s 12 Regional Biocontainment Labs (RBL) to research it's lead defensin mimetic drug candidate, Brilacidin, as a potential novel coronavirus treatment. Mechanism of action studies of Brilacidin and assessing possible synergistic effects with other antivirals are also planned. It is anticipated these tests might be completed within several weeks of the RBL’s receipt of Brilacidin.
February 26, 2020 - Gilead Sciences, Inc. announced the initiation of Phase 3 clinical studies to evaluate the safety and efficacy of Remdesivir in adults who are diagnosed with COVID-19 disease, which is caused by the SARS-CoV-2 coronavirus. These human clinical studies' initiation follows the U.S. Food and Drug Administration’s rapid review and acceptance of Gilead’s investigational new drug filing for Remdesivir to treat COVID-19 patients. Remdesivir is not yet licensed or approved anywhere and has not been demonstrated to be safe or effective for any use.
February 25, 2020 - Vir Biotechnology, Inc. and WuXi Biologics announced a development and manufacturing collaboration to advance and produce human monoclonal antibodies for the potential treatment of COVID-19, a disease caused by the SARS-CoV-2 coronavirus. Vir has identified several monoclonal antibodies that bind to SARS-CoV-2 and is researching to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.
February 25, 2020 - A phase 2 clinical trial of Gilead’s experimental drug remdesivir for the novel coronavirus, according to a posting on a government clinical trials database. The trial will be run by the University of Nebraska Medical Center and the National Institute of Allergy and Infectious Diseases. It will be conducted at up to 50 sites globally.
February 24, 2020 - Cocrystal Pharma, Inc. Announced License Agreement with Kansas State University Research Foundation for Norovirus and Coronavirus Antiviral Compounds. Cocrystal intends to pursue research and development of these antiviral compounds, including preclinical and clinical development. This license advances the Company's antiviral programs significantly by providing potent compounds for further development.
February 23, 2020 - Japan's health minister Katsunobu Kato said the anti-influenza medication Avigan will be used for COVID-19 treatment as part of an observational study.
February 20, 2020 - Beroni Group announced its collaboration with Tianjin University in China to develop a medical solution for the coronavirus (COVID-19) epidemic. A team of scientists from Tianjin University and Beroni Group is now developing a rapid detection method and precision-driven treatment of COVID-19 caused by SARS-CoV-2 infection using nanobody-based technology.
February 20, 2020 - WHO Director-General Tedros Adhanom Ghebreyesus said: "Preliminary results from two clinical trials testing potential treatments for the COVID-19 coronavirus are expected in 3 weeks. Even if people are infected, having better outcomes, saving their lives, is really key." One trial combines HIV drugs Lopinavir and Ritonavir, while the other is testing the antiviral Remdesivir.
February 18, 2020 - China's National Medical Products Administration has approved the marketing of Favilavir, formerly known as Fapilavir, an antiviral medication that has shown efficacy in treating the novel coronavirus COVID-19. Favilavir was developed by Zhejiang Hisun Pharmaceutical, which is the 1st drug that has been approved for marketing in China. Fapilavir is reported to have demonstrated efficacy with minor side effects in an ongoing 70-patient clinical trial in Shenzhen, Guangdong province.
February 17, 2020 - China developed the 5th version for trial implementation of the “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia" based on the previous version's revisions.
February 15, 2020, the CDC announced it had grown the COVID-19 virus in cell culture, which is necessary for further studies, including genetic characterization. The cell-grown virus was sent to NIH’s BEI Resources Repositoryexternal icon for use by the broad scientific community.
February 13, 2020 - Gilead Sciences antiviral drug prevented disease. It reduced the severity of symptoms in monkeys infected with Middle East Respiratory Syndrome (MERS), an infection closely related to the fast-spreading coronavirus that originated in China, reported a study published in the Proceedings of the National Academy of Sciences. The MERS study was supported in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.
February 12, 2020 - Chinese pharma company BrightGene said it has successfully copied Gilead Science's Remdesivir in a Nasdaq-style China disclosure. The Suzhou-based BrightGene also said it has already mass-produced remdesivir's active ingredient and is in the process of turning it into finished doses.
February 7, 2020 - A study published in JAMA reported 'Antibacterial agents are ineffective.' All of the patients in this study received antibacterial agents, 90% received antiviral therapy, and 45% received methylprednisolone. The dose of oseltamivir and methylprednisolone varied depending on disease severity. However, no effective outcomes were observed.
February 4, 2020 - HHS and Regeneron Collaborate to Develop 2019-nCoV Treatment. BARDA and Regeneron now will leverage their partnership agreement to develop multiple monoclonal antibodies that, individually or in combination, could be used to treat this emerging coronavirus, also known as 2019-nCoV. These monoclonal antibodies are produced by a single clone of cells or a cell line with identical antibody molecules. The antibodies bind to certain proteins of a virus, reducing the virus's ability to infect human cells. Medicines developed for 2019-nCoV through the expanded BARDA-Regeneron partnership will leverage Regeneron's monoclonal antibody discovery platform called VelocImmune, part of the company's VelociSuite technology.
February 4, 2020 - A new study published in Nature reports, 'Our findings reveal that remdesivir and chloroquine are highly effective in the control of 2019-nCoV infection in vitro.' Since these compounds have been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they be assessed in human patients suffering from the novel coronavirus disease.
February 4, 2020 - The Lancet - Baricitinib as a potential treatment for 2019-nCoV acute respiratory disease. 'Because the plasma concentration of baricitinib on therapeutic dosing (either as 2 mg or 4 mg once daily) is sufficient to inhibit AAK1, we suggest it could be trialed, using an appropriate patient population with 2019-nCoV acute respiratory disease, to reduce both the viral entry and the inflammation in patients, using endpoints such as the MuLBSTA score, an early warning model for predicting mortality in viral pneumonia.'
February 3, 2020 - Zhang Dingyu, president of Wuhan Jinyintan Hospital, said at the news conference 'that the hospital was the first to use lopinavir/ritonavir, which is sold under the brand name Kaletra and medication for the treatment and prevention of HIV/AIDS, to treat patients with the novel coronavirus. "It seems that Kaletra is effective in patients with early symptoms. It can help prevent the disease from getting severe and life-threatening, but we still need stronger evidence," said Zhang. Zhang warned people that the side effects of Kaletra include gastrointestinal discomfort, allergy, and hepatic damage. Lopinavir/ritonavir is being investigated (Chinese clinical trial registry identifier: ChiCTR2000029308) based on previous studies suggesting possible clinical benefit in SARS and MERS. The research team of Li Lanjuan, one of China's leading scientists in the fight against the novel coronavirus, announced a breakthrough on Tuesday, China's Changjiang daily reported. Preliminary tests showed that two drugs - Abidol and Darunavir – can effectively inhibit the virus in vitro cell experiments, according to Li, a professor at Zhejiang University.
February 3, 2020 - AntiCancer Inc. said, “Oral recombinant methioninase has high potential to slow or arrest infection of 2019-nCoV in patients, with and without symptoms,” said Dr. Qinghong Han, methioninase project leader at AntiCancer. “We will first test methioninase in cultured lung cells infected with 2019-nCoV in vitro, and then test oral recombinant methioninase in patients infected with the virus. We will carry out these tests in China with the appropriate organizations and safety profiles. Oral recombinant methioninase should be an effective therapy for infections caused by the 2019-nCoV since coronaviruses have a special requirement for methionine,”
February 2, 2020 – California-based Gilead Sciences issued a statement announcing Washington State health officials used the unapproved antiviral drug Remdesivir to treat the 1st patient diagnosed with the novel coronavirus 2019-nCoV in the U.S.
January COVID-19 Disease Treatment News
January 31, 2020 — Gilead Sciences stated Merdad Parsey, M.D., Ph.D., Chief Medical Officer, Gilead Sciences: "Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir." Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.
January 27, 2020 - AbbVie’s fixed-dose HIV drug Kaletra—also known as Aluvia, is now recommended as a treatment for pneumonia caused by the new coronavirus known as 2019-nCoV, China’s National Health Commission says in its updated clinical guidance. Kaletra’s 2 antiretroviral components, lopinavir, and ritonavir are protease inhibitors designed to block HIV viral replication. One hypothesis holds that the drugs could do the same with 2019-nCoV, which is believed to have originated from the Chinese city of Wuhan. Although not approved to treat any coronavirus anywhere, it has shown efficacy in at least one case in China's current outbreak.
Thailand doctors combined the anti-flu drug oseltamivir with lopinavir and ritonavir; antivirals used to treat HIV. The ministry was awaiting research results to prove the findings.
Note: This content was last reviewed by health care professionals, such as Dr. Robert Carlson.