COVID-19 Antiviral Treatments - U.S. FDA Authorized
The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for two investigative oral antiviral agents: Paxlovid and Molnupiravir. As a result, on June 27, 2022, the U.S. HHS Office of the Assistant Secretary for Preparedness and Response distributed about Lagevrio (2,055,256) and Paxlovid (3,653,673) oral treatments since late 2021.
Paxlovid - Nirmatrelvir plus PF-07321332 is an orally bioavailable protease inhibitor active against mPRO, a viral protease that plays an essential role in viral replication by cleaving the two viral polyproteins. Paxlovid is authorized in the U.S. for certain adults and children and in Europe and the U.K. for adults.
Lagevrio (Molnupiravir) is the oral prodrug of beta-D-N4-hydroxycytidine, a ribonucleoside with broad antiviral activity against RNA viruses. However, NHC uptake by viral RNA-dependent RNA-polymerases can result in viral mutations and lethal mutagenesis. Therefore, the WHO's ninth update included a conditional recommendation for the treatment with molnupiravir for those at the highest risk of hospitalization on March 3, 2022.
The U.S. CDC published: Interim Clinical Considerations for COVID-19 Treatment in Outpatients on June 15, 2022. And on May 31, 2022, the U.S. NIH published updated treatment guidelines for treating nonhospitalized adults with mild to moderate COVID-19 who are at high risk of disease progression. Additionally, the WHO's Therapeutics and COVID-19: living guideline contains recommendations for therapeutics in treating COVID-19, as do the U.K. and the European Medicines Agency. And On June 8, 2022, the EMA published a list of critical authorized medicines for the COVID-19 public health emergency.
To improve access to Covid-19 treatments, the U.S. administration recently launched the "Test to Treat" initiative with local pharmacies. The CDC reported on June 21, 2022, an analysis of national oral antiviral dispensing data from December 23, 2021–May 21, 2022, highlights a substantial increase in the number of dispensing sites reaching 39,687 sites, 87% of which were pharmacies.
COVID-19 IV Infusion - U.S. FDA Approved
Veklury (remdesivir; GS-5734, DESREM, Redyx) is a nucleotide analog with broad-spectrum antiviral activity. On April 25, 2022, the FDA expanded the approval of Veklury to include certain pediatric patients 28 days of age and older weighing at least 3 kilograms.
Actemra / RoActemra (tocilizumab) is a first-in-class anti-interleukin-6 receptor intravenous (IV) therapy for treating rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and chimeric antigen receptor T-cell induced severe or life-threatening cytokine release syndrome. Actemra was granted EUA for treating COVID-19 in hospitalized adults and children in June 2021 and granted FDA Priority Review on April 3, 2022. On December 7, 2021, the European Commission approved its use for certain COVID-19 patients in Europe, followed by Japan on January 21, 2022. The WHO issued Precalification on February 11, 2022. Since the beginning of the COVID-19 pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide
On December 28, 2021, the FDA expanded the authorization of convalescent plasma with high titers of anti-SARS-CoV-2 antibodies "to treat COVID-19 in patients with an immunosuppressive disease or to receive immunosuppressive treatment, in either the outpatient or inpatient setting. And on March 30, 2022, the peer-review The New England Journal of Medicine published results from a phase 2 clinical study that concluded, 'In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within nine days after the onset of symptoms produced a 54% relative risk reduction for hospitalization."
Medications Repurposed to Treat COVID-19
Eli Lilly's Olumiant (Baricitinib) is a Janus kinase inhibitor. Its active substance, baricitinib, blocks the action of enzymes that play an essential role in immune processes that lead to inflammation. Olumiant was authorized by the FDA on Jul. 28, 2021, to treat certain COVID-19 in hospitalized adults and pediatric patients. And then FDA Approved it on May 11, 2022. On March 3, 2022, the WHO issued a strong recommendation for the treatment with baricitinib. It is available in about 75 countries to treat moderate to severe rheumatoid arthritis adults.
Fluvoxamine is a selective serotonin reuptake inhibitor approved by the U.S. FDA for treating obsessive-compulsive disorder. Fluvoxamine costs about $12 per course. There is insufficient evidence for the COVID-19 Treatment Guidelines Panel to recommend either for or against the use of fluvoxamine to treat COVID-19 says the NIH. Johns Hopkins has posted positive reviews. On April 6, 2022, an original study published by The JAMA Network found a high probability (94.1%-98.6%) that fluvoxamine was associated with a reduced risk for hospitalization, with a frequentist risk ratio of 0.75 (95% CI, 0.58-0.97). On May 10, 2022, an ICER committee voted (7 to 6) to find the current evidence on fluvoxamine acceptable to demonstrate benefit over symptomatic care. On May 16, 2022, the U.S. FDA declined to authorize Fluxoxamine.
Inhaled Budesonide is used to treat Crohn's disease and is in a class of medications called corticosteroids. An investigator-initiated, open-label, randomized clinical trial explored the efficacy of adding inhaled budesonide to usual care to prevent disease progression in patients hospitalized with COVID-19 pneumonia on Feb. 12, 2022 - results suggest that the addition of inhaled budesonide to usual care is safe and showed a reduction in disease progression.
A National Institutes of Health study published by PLOS One on April 18, 2022, suggests the use of ACEIs (blood pressure), ARBs (blood pressure and treat heart failure), statins (cholesterol), and the anticoagulants warfarin, direct-factor Xa inhibitors, and P2Y12 inhibitors in seniors (65+) were linked to a lower risk of COVID-19 infection, with risk reductions ranging from 1% for direct-factor Xa inhibitors to 12% for warfarin.
BMS's ORENCIA® (abatacept) is indicated, and U.S. FDA approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis. ORENCIA is a selective costimulation modulator that disrupts the continuous cycle of T-cell activation. People in the Orencia group had 34.2% better odds of clinical improvement than those in the placebo group.
Kineret is a prescription medicine approved in Europe and the U.S. to treat signs and symptoms of rheumatoid arthritis in adults and those with a Deficiency of Interleukin-1 Receptor Antagonist. The EMA authorized (EMEA/H/C/000363) Kineret's use for certain COVID-19 patients in December 2022. Kineret contains the active substance anakinra.
VIRALEX (Inosine pranobex) 500 mg tablet is an immunomodulatory agent with broad-spectrum antiviral properties authorized in India and the U.K. It enhances both innate & adaptive immunity and strengthens the body's defense response to viral infections. A recent phase 3 study initiated by Themis Medicare found that 80.17% of patients treated with VIRALEX showed clinical improvement on day 6.
Icatibant is sold by Takeda Pharmaceutical Co as Firazyr blocks a protein called bradykinin receptor b2 in the kinin system. The protein is regulated by ACE2 protein on the cell surface that the SARS-CoV-2 coronavirus uses as a gateway for infection.
COVID-19 Treatment Candidates - 2022
Veru Inc. Sabizabulin is an orally bioavailable bis-indole that binds to the "colchicine binding site" of a and b tubulin and inhibits tubulin polymerization at low nanomolar concentrations conducting phase 3 clinical study. Sabizabulin disrupts the microtubule filaments similar to nocodazole and colchicine, the central mechanism contributing to their antiviral and anti-inflammatory activities. The FDA granted Fast Track designation to the sabizabulin COVID-19 Phase 2 study in January 2022. Following the pre-EUA meeting on May 10, 2022, the FDA agreed that the efficacy and safety data from the completed Phase 3 clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome are sufficient to support the submission of a request for EUA.
SaNOtize's Nitric Oxide Nasal Spray represents a safe and effective antiviral treatment that shortens the course of COVID-19 and could prevent the transmission of COVID-19; approved in Singapore, Malaysia, Taiwan, India, and Israel.
Brilacidin (PMX-30063) is a synthetic, non-peptidic small molecule that kills pathogens swiftly, significantly reducing drug resistance development. Brilacidin has been granted U.S. FDA Fast Track designation. Brilacidin exhibits broad-spectrum antiviral activity inhibiting the Omicron (B.1.1.529) and Delta (B.1.617.2) variants of SARS-CoV-2 based on in vitro testing.
Edger's Lambda is a late-stage, first-in-class, type III interferon administered as a single subcutaneous injection that stimulates immune responses critical for developing host protection during viral infections and has been well-tolerated in clinical studies.
NRx Pharmaceuticals's ZYESAMI® (Aviptadil) targets patients with COVID-19 respiratory failure and is available in the U.S. under the Federal Right to Try Law.
Japan-based Shionogi & Co.'s COVID-19 oral drug Xocova (S-217622) is a 3CL protease inhibitor that suppresses virus replication conducting phase 2/3 study. On day four of treatment (following the third dose), the proportion of patients with positive viral titer decreased by approximately 90% versus placebo. Authorization in Japan was pending.
RedHill Biopharma's (RHB-107, ABC294640) Opaganib, a first-in-class new chemical entity, is a sphingosine kinase-2 (SK2) selective inhibitor in oral pill form with dual anti-inflammatory and antiviral activity. Opaganib's unique human host-targeted, dual antiviral, and an antiinflammatory suggested mechanism is expected to act independently of viral spike protein mutations and remain effective against Omicron sub-variants BA.2, XE, and other emerging and future variants. Regulatory discussions are in progress, with opaganib data submissions in the U.S., Europe, UK, and additional countries.
Molecular Partners AG's Ensovibep is a DARPin therapeutic candidate designed specifically to inhibit target cell entry of SARS-CoV-2. DARPins (Designed Ankyrin Repeat Proteins) are mono or multi-specific protein-based therapies designed to engage their targets for various effects. Novartis requested a EUA from the U.S. FDA for ensovibep on Feb. 10, 2022.
Enanta Pharmaceuticals's EDP-235 is a coronavirus 3CL protease inhibitor specifically designed as a once-daily, oral treatment for COVID-19. It is in a first-in-human Phase 1 study and recently was granted FDA Fast Track Designation.
Adagio Therapeutic's Adintrevimab (ADG20) is a potent, broadly neutralizing antibody for both the prevention and treatment of COVID-19, including disease caused by most variants, as either a single or combination agent, in phase 2/3 studies.
Sorrento Therapeutics Abivertinib is a novel dual-target, small molecule tyrosine kinase inhibitor designed to selectively target mutant forms of the epidermal growth factor receptor and Bruton's tyrosine kinase, a third-generation EGFR inhibitor. The FDA issued clearance for a Phase 2/3 Study for Abivertinib in Treatment of Hospitalized Patients With Severe Pneumonia Due to COVID-19.
Sorrento Therapeutics STI-1558 is a potent Mpro inhibitor with an IC50 value of 2.7 nM and has demonstrated potent antiviral activity against all COVID-19 variants studied, including Omicron, with an IC90 value between 14 nM and 41 nM (an IC50/IC90 is the concentration of drug need to produce a 50%/90% inhibition of activity) in vitro following infection of human bronchial epithelial cells. It is also a Cathepsin L inhibitor, which may block effective viral entry into host cells. Sorrento expects the human efficacious dose to be between 300 mg and 600 mg BID without the need for a Ritonavir-boost.
Kintor Pharmaceutical's Proxalutamide is an ACE2 and TMPRSS2 (transmembrane protease, serine 2) proteins inhibitor that inhibits the entry of the SARS-CoV-2 coronavirus into host cells, conducting phase 3 clinical research.
Sen-Jam Pharmaceutical's investigational therapeutic SJP-002C for the treatment of COVID-19 is actively enrolling clinical trial participants under a co-development agreement with Duke-NUS and Duke University School of Medicine.
Synairgen plc's SNG001 is a pH-neutral formulation of interferon-beta (IFN-beta) for inhalation that is delivered directly into the lungs using a mesh nebulizer, currently being investigated as a potential host-directed antiviral treatment for patients hospitalized with COVID-19, and due to viral infections such as influenza, Respiratory Syncytial Virus, and para-influenza.
COVID-19 Treatment Guidelines
The Public Readiness and Emergency Preparedness Act passed in September 2021 expanded licensed pharmacists' authority to order and administer oral, intramuscular, and subcutaneous COVID-19 therapeutics. However, the Paxlovid EAU does not authorize pharmacists as prescribers.
U.S. NIH - These sections summarize the data on remdesivir, chloroquine, and other antiviral medications: Highlighted Sections and What's New as of Feb. 24, 2022; U.K. NHS - COVID-19 community-based treatments. The NHS recommends antiviral treatments for people with COVID-19 who are at risk of becoming seriously ill; Europe / EMA - COVID-19 treatment updates as of Feb. 25, 2022; WHO - The 9th version of the WHO's Therapeutics and COVID-19: a living guideline.
COVID-19 Treatments Effectiveness Against Variants
As of June 16, 2022, the U.S. NIH OpenData portal published real-time antiviral effectiveness data regarding the impact of SARS-CoV-2 variant Omicron sublineages, as does the U.K.'s CoVariants and the GISAID Initiative tracks variants worldwide.
COVID-19 Antivirals & Treatment News For 2022
June 23, 2022 - Innovation Pharmaceuticals reported the Company’s defensin-mimetic drug candidate Brilacidin exhibited broad-spectrum antiviral activity and inhibited the Omicron and Delta variants of the SARS-CoV-2 virus based on in vitro testing.
June 21, 2022 - The U.S. CDC confirmed when administered as an early-stage treatment, Paxlovid might prevent COVID-19–related hospitalization among persons with mild-to-moderate COVID-19 who are at risk for progression to severe disease. And the recurrence of COVID-19 symptoms after Paxlovid treatment might also be related to other factors, including viral reinfection or the emergence of treatment-resistant mutations.
June 14, 2022 - Pfizer Inc. confirmed it would cease enrollment into the Paxlovid EPIC-SR trial due to the low rate of hospitalization or death in the standard-risk population.
June 12, 2022 - A non-peer-review study published by the ACTIV-6 Study Group concluded Ivermectin dosed at 400 mcg/kg daily for 3 days in a phase 3 clinical trial resulted in less than one day of shortening of symptoms and did not lower the incidence of hospitalization or death among COVID-19 outpatients during the delta and omicron variant time periods.
June 7, 2022 - Original Research - Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 - Conclusion: The findings suggest there are additional important clinical benefits of molnupiravir beyond the reduction in hospitalization or death.
June 2, 2022 - Bristol Myers Squibb announced topline results from the Phase 3 Accelerating COVID-19 Therapeutic Interventions and Vaccines Immune Modulators clinical trial, sponsored by the NIH. The risk of death was lower for participants who received Orencia at 11%, versus 15% for those who received placebo, and the odds of dying were 37.4% lower. The relative improvement in mortality was similar in both moderately and severely ill participants. People in the Orencia group had 34.2% better odds of clinical improvement than those in the placebo group.
May 25, 2022 - Shanghai Junshi Biosciences Co., Ltd.'s study results show that compared to PAXLOVID, VV116 (JT001) provided patients with a shorter median time to sustained clinical recovery, achieving statistical superiority.
May 24, 2022 - The U.S. CDC issued Health Advisory CDCHAN-00467 regarding COVID-19 Rebound cases after Paxlovid treatment.
May 20, 2022 - A non-peer-reviewed retrospective cohort study evaluated the clinical and virologic outcomes associated with molnupiravir and nirmatrelvir/ritonavir use in COVID-19 patients hospitalized in Hong Kong during the Omicron BA.2 variant wave. Compared to no treatment, oral antiviral use was associated with a significantly lower risk of the composite outcome of disease progression (molnupiravir: HR=0.53, 95%CI=0.46-0.62, p<0.001; nirmatrelvir/ritonavir: HR=0.33, 95%CI=0.24-0.46, p<0.001) than non-use.
May 16, 2022 - The U.S. FDA issued - Memorandum Explaining Basis for Declining Request for Emergency Use Authorization of Fluvoxamine Maleate - declining to authorize Fluvoxamine.
May 16, 2022 - Synairgen plc announced the first presentation of the full data analysis from its Phase 3 SPRINTER trial evaluating the efficacy and safety of SNG001 in patients hospitalized with COVID-19. These analyses showed stronger treatment effects with SNG001 in these high-risk patient sub-groups, with the strongest effect observed in those who had clinical signs of compromised respiratory function.
May 12, 2022 - Hyundai Bioscience announced that the phase 2 clinical trial of CP-COV03 for COVID-19 patients has begun. CP-COV03 is an orally administered antiviral drug (active ingredient: niclosamide) developed as a universal treatment for viral diseases including COVID-19.
May 11, 2022 - The U.S. FDA Approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.
May 11, 2022 - "The discussion with FDA in the Pre-EUA meeting has established a direct path forward to expedite the availability of sabizabulin to the high-risk hospitalized patients with COVID-19," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "In Phase 3 COVID-19 clinical study, sabizabulin demonstrated a clear mortality benefit in hospitalized moderate to severe COVID-19 patients on the current standard of care with no significant safety signals," Dr. Steiner continued.
May 2, 2022 - The Lancet published: Remdesivir and three other drugs for hospitalized patients with COVID-19: final results of the WHO Solidarity randomized trial and updated meta-analyses. Interpretation: Remdesivir has no significant effect on patients with COVID-19 who are already being ventilated and has a small effect against death and/or progression to ventilation.
April 25, 2022 - Veru Inc. reported that sabizabulin treatment resulted in an 82% relative reduction in deaths (p=0.0442) in the ITT population. Further, sabizabulin treatment reduced mean days in the ICU from 9.6 ± 12.40 days in the placebo group to 2.6 ± 5.78 days (p=0.0261) in the sabizabulin treated group, a 73% relative reduction in the mean days in the ICU. Similarly, there was a reduction in mean days on mechanical ventilation from 5.1 ± 11.24 days in the placebo group to 1.2 ± 6.06 days (p=0.1437), a 78% relative reduction in days on mechanical ventilation. Sabizabulin was safe and well-tolerated, with no treatment-related adverse events observed.
April 23, 2022 - Shionogi & Co., Ltd. announced new results from two late-breaking presentations of S-217622: S-217622 demonstrated rapid clearance of the infectious SARS-CoV-2 virus; on day four of treatment (following the third dose), the proportion of patients with positive viral titer decreased by approximately 90% versus placebo; S-217622 shortened infectious virus shedding by 1-2 days versus placebo; S-217622 showed a significant reduction in viral RNA on days 2, 4, 6 and 9 versus placebo (difference versus placebo in the Least Squares mean change from baseline in viral RNA; under -1.0 logx copies/mL on day four at each dose).
April 21, 2022 - ExThera Medical announced data demonstrating safety in treating critically ill COVID-19 patients with the Seraph® 100 Microbind® Affinity Blood Filter. The device was investigated under the PURIFY OBS multicenter observational clinical study facilitated by the Henry Jackson Foundation for the Advancement of Military Medicine and the Uniformed Services University of the Department of Defense - 'a pathogen-agnostic device that removes viral particles directly from the bloodstream is an attractive potential therapy.'
April 11, 2022 - RedHill Biopharma Ltd. announced study results in which opaganib (ABC294640), a leading oral drug candidate for hospitalized patients with moderate to severe COVID-19, was observed to have potent in vitro efficacy against the Omicron SARS-CoV-2 variant, while maintaining host cell viability and remain effective against Omicron sub-variants BA.2, XE and other emerging and future variants.
April 11, 2022 - Veru Inc. announced positive efficacy and safety results from a Phase 3 COVID-19 clinical trial evaluating oral sabizabulin 9 mg in hospitalized COVID-19 patients at high risk for the Acute Respiratory Distress Syndrome. The Independent Data Safety Monitoring Committee unanimously recommended that the study be halted early due to efficacy, and they further remarked that no safety concerns were identified.
April 6, 2022 - The JAMA Network published the results from an Original Investigation that found under a variety of assumptions, fluvoxamine showed a high probability of being associated with reduced hospitalization in outpatients with COVID-19. Depending on the scenario, the probability of any association with reduced hospitalization ranged from 94.1% to 98.6%, and the probability of moderate association ranged from 81.6% to 91.8%.
April 6, 2022 - Tonix Pharmaceuticals Holding Corp. announced the U.S. FDA cleared the Investigational New Drug application to support a Phase 2 clinical trial with TNX-102 SL1 as a potential treatment for a subset of patients with Long COVID Syndrome whose symptoms overlap with fibromyalgia. Long COVID is now known officially as the Post-Acute Sequelae of COVID-19 (PASC2).
April 6, 2022 - Kintor Pharmaceutical Limited announced the top-line results of the Phase III MRCT of proxalutamide in outpatients with mild to moderate COVID-19 regardless of vaccination status and risk factors. Data from the study demonstrated that the protection rate of patients in the trial (regardless of age or risk factors) treated with proxalutamide for more than seven days reached 100% (p < 0.02).
April 3, 2022 - The U.S. FDA granted Priority Review to Actemra to treat certain COVID-19 hospitalized adults.
March 30, 2022 - Adagio Therapeutics, Inc. reported that the primary endpoints were met with statistical significance for all three indications in its ongoing global Phase 2/3 clinical trials evaluating its investigational drug adintrevimab (ADG20) as pre-and-post-exposure prophylaxis and treatment for COVID-19.
March 29, 2022 - Enanta Pharmaceuticals, Inc. announced that the U.S. FDA granted Fast Track designation for EDP-235, its coronavirus 3CL protease inhibitor designed as a once-daily, oral treatment for COVID-19.
March 25, 2022 - P.E.I.'s Chief Public Health Officer, Dr. Heather Morrison, stresses these treatments (Paxlovid) are not a replacement for vaccines but can help people who are classified as high risk, such as people 50 or older, the immunocompromised, or others with underlying conditions or who are not fully vaccinated.
March 10, 2022 - The NEJM published a Correspondence: Efficacy of Antibodies and Antiviral Drugs against Covid-19 Omicron Variant. These results suggest that all three of these compounds may show efficacy in treating patients infected with the omicron variant.
March 9, 2022 - Pfizer Inc. announced today that it had initiated a Phase 2/3 study, EPIC-PEDS to evaluate the safety, pharmacokinetics, and efficacy of PAXLOVID in nonhospitalized, symptomatic pediatric participants with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease. Cohort 1 includes participants aged 6 to 17 weighing at least 40 kg, and Cohort 2 includes those aged 6 to 17 weighing more than 20 kg and less than 40 kg.
March 9, 2022 - Romark Lab announced results of its Vanguard Co-V clinical trial of NT-300 (nitazoxanide extended-release tablets, 300 mg) for treatment of mild or moderate COVID-19 had been published in Lancet's eClinicalMedicine, included an 85% reduction in risk of severe illness for patients treated with NT-300 compared to placebo (1/184 [0.5%] vs. 7/195 [3.6%] for placebo, p=0.07) and 5.2-day reduction in median time to return to usual health for patients with mild illness treated with NT-300 (p<0.01).
March 8, 2022 - The JAMA Network published an Original Investigation - Association Between Dexamethasone Treatment After Hospital Discharge for Patients With COVID-19 Infection and Rates of Hospital Readmission and Mortality - Conclusions and Relevance: In this cohort study of patients with COVID-19, continuing treatment with dexamethasone, 6 mg/d, at discharge was not associated with a reduction in 14-day all-cause readmission or mortality. This finding suggests that dexamethasone should not be routinely prescribed beyond discharge for individuals with COVID-19.
March 3, 2022 - The WHO issued a conditional recommendation for the use of Molnupiravir for patients with non-severe COVID-19, conditional for those at the highest risk of hospitalization (excluding pregnant or breastfeeding women and children).
March 2, 2022 - Sorrento Therapeutics, Inc. announced that new preclinical results demonstrate that pretreating an animal with intranasal neutralizing antibody (STI-9199) twenty-four hours prior to being exposed to the SARS-CoV-2 virus prevents productive infection in the treated animals.
March 1, 2022 - The largest clinical review of immune responses to paracetamol, non-steroidal anti-inflammatory drugs, and opioid analgesics, with a focus on infectious diseases, has provided insights into the unintended impacts of these commonly used medicines.
March 1, 2022 - RedHill Biopharma Ltd. announced positive top-line results from the Phase 2 part of the Phase 2/3 study of once-daily oral RHB-107 in nonhospitalized symptomatic COVID-19 patients, predominantly conducted in the U.S. - 100% reduction in hospitalization due to COVID-19 with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the placebo-controlled arm; 87.8% reduction in reported new severe COVID-19 symptoms after treatment initiation.
February 24, 2022 - The Florida Department of Health issued a Provider Alert - New COVID-19 Guidance for Health Care Practitioners. 'When recommending COVID-19 treatment options for patients' individualized health care needs, physicians should exercise their individual clinical judgment and expertise based on their patients' needs and preferences.'
February 24, 2022 - The U.S. NIH published revised COVID-19 Treatment Guidelines for Ritonavir-Boosted Nirmatrelvir (Paxlovid).
February 19, 2022 - India-based media reported Hetero Pharma announced the oral antiviral Movfor (Molnupiravir) along with the standard of care (SOC) reduced the risk of COVID-19 hospitalization by 65% compared to SOC alone.
February 18, 2022 - The JAMA Network published a peer-reviewed study that concluded: In this randomized clinical trial of 500 high-risk, older patients hospitalized with COVID-19, ivermectin treatment did not prevent progression to severe disease.
February 16, 2022 - Enanta Pharmaceuticals, Inc. announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-235, a coronavirus 3CL protease inhibitor designed as a once-daily, oral treatment for COVID-19.
February 15, 2022 - A non-peer-reviewed study concluded by saying, 'our study provides evidence that S-217622, an antiviral agent that is under evaluation in phase II/III clinical trial, possesses remarkable antiviral potency and efficacy against SARS-CoV-2 and is a prospective oral therapeutic option for COVID-19.'
February 14, 2021 - Florida-based Veru Inc. announced that an Independent Data Monitoring Committee concluded the phase 3 clinical study evaluating daily Sabizabulin (VERU-111) 9 mg oral dosage for up to 21 days should continue as originally designed.
February 11, 2022 - The WHO granted prequalification of Actemra/RoActemra for patients with severe or critical COVID-19.
February 10, 2022 - China issued authorization for Paxlovid use.
February 10, 2022 - Japan's health ministry granted fast-track approval for the use of Paxlovid, an oral COVID-19 pill developed by Pfizer Inc.
February 10, 2022 - Switzerland-based Molecular Partners AG was informed by its partner Novartis that the company had requested Emergency Use Authorization from the U.S. FDA for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.
February 7, 2022 - The peer-reviewed journal Nature published: Pyrimidine inhibitors synergize with nucleoside analogues to block SARS-CoV-2; that found that combining pyrimidine biosynthesis inhibitors with antiviral nucleoside analogues synergistically inhibits SARS-CoV-2 infection in vitro and in vivo against emerging strains of SARS-CoV-2 suggesting a clinical path forward.
February 4, 2022 - MarketWatch reported full-year sales of Gilead Sciences Inc.'s antiviral Veklury ($5.5 billion), Merck & Co. Inc.'s molnupiravir (nearly $1 billion, according to year-end earnings reports.
January 31, 2022 - Veru Inc. announced that the U.S. FDA granted Fast Track designation to the Phase 3 registration program for the investigation of sabizabulin, a novel, proprietary, oral cytoskeleton disruptor with both antiviral and anti-inflammatory properties, to combat COVID-19 infection and the cytokine storm that is responsible for Acute Respiratory Distress Syndrome and death.
January 30, 2022 - New York City Mayor Eric Adams announced the city would begin offering free, same-day, at-home delivery of antiviral COVID-19 pills.
January 27, 2022 - The EMA's vaccine committee recommended Paxlovid for treating COVID-19 in adults who do not require supplemental oxygen and are at increased risk of severe disease. The EMA's recommendation was sent to the European Commission for a rapid decision applicable in all E.U. Member States. This action indicates that Paxlovid will be the first oral antiviral recommended in the E.U. to treat COVID-19. Furthermore, based on recent laboratory studies, not human clinical trials, Paxlovid is expected to be active against Omicron.
January 27, 2022 - Texas-based TFF Pharmaceuticals, Inc. announced that it had completed enrollment of 40 healthy subjects in its Phase 1 clinical trial of a dry powder formulation of niclosamide, an antiviral treatment with the potential to address COVID-19 and other respiratory viral diseases. Originally approved as an oral anthelmintic drug by the U.S. FDA in 1982, niclosamide was recently shown to exhibit potent antiviral activity against SARS-CoV-2.
January 26, 2022 - The U.K. government confirmed the PANORAMIC study, run by the University of Oxford and supported by the National Institute for Health Research has 5,171 participants enrolled. Through the Antivirals Taskforce, the U.K. has procured 4.98 million courses of antivirals, including 2.23 million courses of molnupiravir and 2.75 million courses of Paxlovid PF-07321332+ritonavir.
January 26, 2022 - Researchers based in Japan submitted a Correspondence was published by the NEJM - Efficacy of Antibodies and Antiviral Drugs against Covid-19 Omicron Variant. The omicron variant has mutations in both the RNA-dependent RNA polymerase (RdRp) and the main protease of SARS-CoV-2, which are targets for antiviral drugs such as RdRp inhibitors (remdesivir and molnupiravir), and the primary protease inhibitor Paxlovid which arouses concern regarding the decreased effectiveness of these drugs against Omicron. Therefore, we tested these antiviral compounds for their efficacy against Omicron. The in vitro 50% inhibitory concentration (IC50) values of each compound were determined against NC928, NC002, HP127, HP01542, TY7-503, and UW5250. The susceptibilities of Omicron to the three compounds were similar to those of the early strain (i.e., IC50 values for remdesivir, molnupiravir, and Paxlovid that differed by factors of 1.2, 0.8, and 0.7, respectively). These results suggest these compounds may show efficacy for treating patients infected with the omicron variant.
January 21, 2022 - The U.S. FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain nonhospitalized adults and pediatric patients to treat mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization. The agency also revised the EUA for Veklury to additionally authorize the drug for the treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including the hospitalization of death.
December 22, 2021 - The U.S. FDA issued a EUA for Pfizer's Paxlovid for oral use for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients with positive results of direct SARS-CoV-2 testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated within five days of symptom onset.