COVID-19 Disease Treatments
The U.S. Food and Drug Administration (FDA) has not fully approved any medication for treating people infected with the novel coronavirus SARS-CoV-2, which causes COVID-19 disease in humans.
People infected with this new betacoronavirus have reported a wide range of symptoms reported – ranging from mild symptoms to severe illness - often appearing 2-14 days after exposure to the SARS-CoV-2 virus. The FDA has granted emergency use authorizations for some medicines to be used for certain patients when hospitalized with COVID-19 disease.
Late-Stage COVID-19 Disease Therapies: experimental
- Veklury (Remdesivir; GS-5734) is an investigational nucleotide analog with broad-spectrum antiviral activity. The U.S. FDA broadened the scope of the existing emergency use authorization for Veklury to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of the disease.
- Actemra / RoActemra, plus remdesivir, phase 3 study for hospitalized patients with severe COVID-19 pneumonia. This study was updated on July 7, 2020.
- Olumiant (baricitinib) an oral JAK1/JAK2 inhibitor, is being 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 in combination with remdesivir versus those treated with remdesivir.
- Dexamethasone (glucocorticoid) reduced deaths in hospitalized patients with severe COVID-19 disease by one-third compared to those receiving usual care, according to the RECOVERY trial.
- Aviptadil (RLF-100) is a formulation of synthetic human Vasoactive Intestinal Peptide, which is known to target the VPAC1 receptor of the ATII cell and to protect 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.
- Convalescent Plasma Therapy - The U.S. FDA issued updated guidance to provide recommendations to healthcare providers 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. This guidance was updated on September 2, 2020. There is information that suggests convalescent plasma might help some patients recover from COVID-19. COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product. The use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.
Early-stage SARS-CoV-2 coronavirus therapies: experimental
- Eli Lilly's LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2 coronavirus. Lilly reported the rate of hospitalizations and ER visits was 1.7 percent (5/302) for LY-CoV555 versus 6 percent (9/150) for placebo--a 72 percent risk reduction in this limited population.
- Regeneron REGN-COV2 is an investigational dual antibody cocktail for the prevention and treatment of COVID-19 disease. REGN-COV2 comprises monoclonal antibodies (REGN10933 and REGN10987) and was designed to block the infectivity of the SARS-CoV-2 coronavirus.
- 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.
- Plaquenil (Hydroxychloroquine) is FDA-approved to treat autoimmune conditions such as malaria, chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis, and appears to inhibit coronavirus replication in vitro.
- Avigan (favipiravir) (Avifavir) antiviral was approved in 2014. Glenmark reported on July 22, 2020, Favipiravir showed numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall population as measured by the median time until cessation of oral shedding of virus in the Favipiravir treatment arm.
October 2020 COVID-19 Treatment News
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 for evaluation of 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, which is 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 has 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 for the development and supply of AZD7442, the company's experimental long-acting antibody combination. Additionally, AstraZeneca stated clinical trials of AZD7442 will enroll over 6,000 adults for the prevention of 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 plans to make these therapies broadly available to patients. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of 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 has 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 that was selected based on its potential to neutralize the virus, 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 now expand globally to additional sites in North America, South America, and Europe.
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 how SARS-CoV-2—the virus that causes COVID-19—affects different systems in the body, and identify immune correlates. This regulatory science project could potentially 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. For adults not receiving mechanical ventilation or extracorporeal membrane oxygenation, a 5-day course of remdesivir may provide similar benefits to and fewer harms than a 10-day course.
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 compared to the 0.3 mg/kg cohort. In addition, the results showed increased levels of 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 use by President Trump, which was provided in response to an Individual Patient Investigational New Drug application submitted by the President’s physicians.
October 1, 2020 - The FDA revised it's 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 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. STI-1499 nAb has been cleared by the FDA 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 for the use of 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 currently, the data are 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 that patients with COVID-19 associated pneumonia who received Actemra® (tocilizumab) plus standard of 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 rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of 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 the continuation of its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for 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. Sorrento previously announced, in preclinical studies, 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 for SARS-CoV-2, the novel coronavirus responsible for COVID-19. In human lung epithelial cell line experiments performed at the RBL, Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed statistically significant and synergistic inhibition of 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 will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. REGN-COV2 comprises 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 in comparison with remdesivir. Study investigators noted an approximately 1-day reduction in median recovery time for the overall patient population treated with baricitinib in combination 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 has been cleared for patient enrollment in India. Artemisinin can target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. Viral replication cannot occur without TGF-β. Artemisinin, purified from a plant Artemisia annua, is able to inhibit TGF-β activity and is able to 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. In addition, all of these patients were 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 for the treatment of 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 and 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 the total target of randomized patients, 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 aim of the COMET-ICE study, which will enroll approximately 1,300 patients worldwide who have an early symptomatic infection, is to 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. The study will be conducted by investigators 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 prior to 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 has received approval from the U.S. FDA to start enrolling 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 for the treatment of 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 have been dosed in Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19 disease.
August 25, 2020 - Capricor Therapeutics announced that the U.S. FDA has 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 for 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 to be in the low micromolar range.
August 24, 2020 - Tiziana Life Sciences plc announced that the US Patent and Trademark Office has 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 that they are 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 results of 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 rates of improvement and mortality 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. In addition, 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, as well as the regulatory authorities in the Philippines.
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 planned. 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 used in combination with niclosamide. TFF technology is used in oral and inhalation versions of niclosamide, potentially for COVID-19 disease, as well as other niclosamide-based therapies.
August 11, 2020 - UC San Francisco scientists announced they have 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 replication of a broad range of respiratory viruses, including the SARS-CoV-2 coronavirus. Nitazoxanide has also been shown to inhibit replication of MERS, and other coronaviruses, as well as influenza viruses, rhinoviruses, parainfluenza viruses, RSV 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 to a virus-targeted mechanism.
August 11, 2020 - SAB Biotherapeutics announced that the first participant has 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 the development of potential COVID-19 therapeutics. Given the urgent nature of the pandemic 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 may 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 has 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-19 from replicating and to 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 has been successfully dosed in the 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 for the prevention of 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. At the same time, 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 a Phase II clinical trial for the treatment of 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 has 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 has 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 results of the patient safety data 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 has confirmed the antiviral activity of WP1122 against coronavirus.
July 21, 2020 - Selva Therapeutics, Inc. announced that the company has raised $3 million, with the proceeds of the financing to be used to advance SLV213 into clinical trials as an oral drug candidate for the treatment of COVID-19. In addition, SLV213 has the potential to be a treatment for multiple infectious diseases caused by other coronaviruses, such as SARS, and also Ebola viruses, Nipah virus, and Chagas disease, a parasitic disease currently 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, in hospitalized COVID-19 patients. The company stated patients who received SNG001 had a 79% lower risk of developing severe COVID-19 disease, compared to placebo. And, 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 the impact of BTK inhibitors to other types of therapy.
July 17, 2020 - Study: In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were 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 to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine.
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 results of the pivotal study 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. The exigencies of the pandemic 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. and its subsidiary, ViralClear Pharmaceuticals, Inc., announced the enrollment of adult patients for its Phase II trial for merimepodib, a broad-spectrum, 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 the potential clinical impact of this treatment. 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 has 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 has 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 has 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 recommendation from the Solidarity Trial’s International Steering Committee to discontinue the clinical trial of hydroxychloroquine.
July 2, 2020 - Abivax SA announced that the first patient has been treated in its Phase 2b/3 study of ABX464 in COVID-19 patients at the University Hospital Center in Nice, France. The main goal of the trial is to measure the potential of ABX464 to limit viral replication as well as 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 as well as in the UK, Italy, and Brazil and expects authorization to follow in Spain and additional Latin American countries with high infection rates, including Mexico, Chile, and 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 a more severe form of the disease called 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 type of 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 has 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 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to Acute Respiratory Distress Syndrome.
- June 25, 2020 - EMD Serono announced the U.S. FDA has cleared its investigational new drug application for M5049 for the treatment of 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, which is a wide spectrum anti-viral agent with demonstrated activity against SARS-CoV-2 in the nanomolar range comparable to remdesivir, however, with 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 has 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 has 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 has been enrolled in a 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 as a treatment for adults with moderately to severely active rheumatoid arthritis. A 2-mg is indicated for the treatment of adult patients with 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 has 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, its investigational dual antibody cocktail for the prevention and treatment of 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 has 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 has dosed the first healthy volunteer in a study of a potential 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 has 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 a reduction in the overactive immune response in most of 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 a novel antibody therapeutics to prevent and treat COVID-19, the pandemic respiratory disease caused by the SARS-CoV-2 virus. The focus of the collaboration is 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 has received clearance from the U.S. FDA for its recently submitted Investigational New Drug application for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with COVID-19. Ifenprodil is an NMDA receptor antagonist.
June 3, 2020 - The leader of the World Health Organization (WHO) announced they will 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 with 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, although the trial was terminated early and may have been underpowered to detect a clinically important difference, reported a study published by JAMA.
June 1, 2020 - Eli Lilly announced patients have 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 the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of 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 compared with those in the standard of care group.
June 1, 2020 - OPKO Health, Inc. announced that the U.S. FDA has authorized OPKO to undertake a Phase 2 trial with RAYALDEE® as a treatment for 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 has 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 therapeutic 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 on the basis of findings from an analysis that showed a shortened time to recovery in 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 has been testing 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 has 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 and 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. and its subsidiary, ViralClear Pharmaceuticals, Inc., announced the closing of a $10.8 million common stock financing. ViralClear plans to use the proceeds of this offering 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 prior to infection at a concentration of 10μM as compared to vehicle control.
May 19, 2020 - CytoDyn Inc. announced it will be coordinating with the NIH of Mexico and providing leronlimab for a clinical trial for the treatment of severe - critical COVID-19 disease population in Mexico.
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 can effectively find the neutralizing antibody we were thrilled."
May 18, 2020 - BioSig Technologies, Inc. announced that the U.S. FDA has completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or 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 will 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 an in vitro virus infection experiment at a very low 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 has 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 in alleviating symptoms and shortening 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 in the investigation and development of an antibody cocktail (COVI-SHIELD™) to potentially treat COVID-19.
- May 8, 2020 - Arch Biopartners Inc. announced it has 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 has cleared the Company’s IND application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome.
- May 4, 2020 - Junshi Biosciences and Eli Lilly and Company announced they have entered into an agreement 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 have 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 for the treatment of 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 in reducing 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 has 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 subsidiary of Fujifilm Corporation.
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), for the treatment of patients with COVID-19, which has been authorized by the Spanish Medicines and Healthcare Products Agency.
April 27, 2020 - Tocilizumab was reported to improve clinical outcomes of patients with moderate or severe COVID-19 pneumonia. Patients were selected on the basis of 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 has submitted an IND application to the FDA to study its investigational drug, OT-101, for the treatment of 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 not only the virus replication but also the often lethal clinical sequelae of COVID-19, including pneumonia and fibrosis.
April 27, 2020 - Innovation Pharmaceuticals announced the Company has been informed by researchers at the U.S. Regional Biocontainment Laboratory (RBL) that continued coronavirus (COVID-19) testing of 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 rapidly advance Brilacidin testing in human trials. Results from 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 will 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 has signed an agreement with Sterling Medical Devices to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus. The company announced last week 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 rapidly develop a novel endotracheal device to help 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 the use of 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 entered into an agreement 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 will advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome. And, the company entered into an agreement 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 has 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 that has been implicated in these severe COVID-19 cases. ATYR1923 has also been shown to improve lung function, as well as to 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 will 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, as a result of 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, to 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 of 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 and reduce the amount of virus 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 who were 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. The detailed results of this analysis 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 crucial role of the gastrointestinal (GI) tract in COVID-19 severity and transmission.
- April 9, 2020 - Gilead Sciences increased the number of participants in 2 ongoing clinical trials for remdesivir, its experimental treatment for COVID-19 disease.
- April 9, 2020 - Pfizer confirmed a lead compound and analogues are potent inhibitors of the SARS-CoV-2 3C-like (3CL) protease, based on the results of initial screening assays. In addition, 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 assessment of the suitability of the lead molecule 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 the 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, the virus 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, with the primary endpoint being 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 as a treatment for 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 roles in cancer, XPO1 also facilitates the transport of several viral proteins from the nucleus of the host cell to the cytoplasm1, and it amplifies the activities of pro-inflammatory transcription factors.
April 6, 2020 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have 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 has 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. This action by the FDA 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 has 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 current major epicenters of the pandemic.
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 - FDA is taking the lead role on 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 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 has 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’s aim is 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 that an additional 3 critically ill COVID-19 disease patients have been treated with leronlimab. These additional patients increase the total to 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 recent decision by the U.S. FDA to grant emergency expanded access that allows INOpulse to immediately be used for the treatment of COVID-19 under the care and supervision of their physician.
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 is supporting clinical trials needed before the medicine, which U.S. President Donald Trump also has been promoting, can be approved for use against the coronavirus.
March 25, 2020 - Vir Biotechnology, Inc. announced that it has identified multiple human monoclonal antibody (mAb) development candidates that neutralize SARS-CoV-2, the virus responsible for COVID-19. The ability of this antibody 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 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved. Vir believes that the conservation of this epitope will make it more difficult for escape mutants to develop.
March 24, 2020 - Aldeyra Therapeutics, Inc. announced that it will 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 the expansion of 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 issued a statement on access to Remdesivir outside of clinical trials. To streamline the emergency access process, Gilead is currently in the process of transitioning from individual compassionate use requests to expanded access programs. This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data 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 for the treatment of malaria, lupus erythematosus, and rheumatoid arthritis.
March 19, 2020 - Roche announced they 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, in order 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 have 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 patients who are severely or critically ill 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 has initiated a program to discover direct-acting antiviral drug candidates for the treatment of patients infected with the novel coronavirus SARS-CoV-2, which 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 who identified a cellular protein that is important for the entry of 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 will 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 rapidly help confront the emerging worldwide coronavirus crisis.
- 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, along with 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. The initiation of these human clinical studies follows the U.S. Food and Drug Administration’s rapid review and acceptance of Gilead’s investigational new drug filing for Remdesivir for the treatment of 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 a number of monoclonal antibodies that bind to SARS-CoV-2 and is conducting research 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 along with the National Institute of Allergy and Infectious Diseases and 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 from Beroni Group is now working to develop 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 revisions of the previous version.
February 15, 2020, the CDC announced it had grown the COVID-19 virus in cell culture, which is necessary for further studies, including for additional 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 and 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 ability of the virus 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 should 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 a 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 major 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, who is also 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 issued a statement from 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 the current outbreak in China.
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.