Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. REGN announced that its phase III outcomes trial on REGEN-COV (casirivimab with imdevimab) in high-risk non-hospitalized COVID-19 patients was successful.
The study evaluated the company’s investigational cocktail antibody, REGEN-COV, in infected non-hospitalized patients (n=4,567).
The study met its primary endpoint, showing that the investigational REGEN-COV significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo. REGEN-COV also met all secondary endpoints in the phase III outcomes trial, including the ability to reduce symptom duration.
Separately, a companion dose-ranging phase II study of 803 outpatient COVID-19 patients was conducted to evaluate the antiviral effect of several different REGEN-COV doses (IV: 2,400 mg, 1,200 mg, 600 mg and 300 mg; SC: 1,200 mg and 600 mg). All tested doses met the primary endpoint, rapidly and significantly reducing patients' viral load. Each dose demonstrated similar efficacy, including the lowest doses tested (IV: 300 mg; SC: 600 mg).
Based on these encouraging data, Regeneron will share new data with regulatory authorities immediately and request that a lower 1,200 mg dose be added to the Emergency Use Authorization.
These phase III data will also form the basis for a full Biologics License Application.
We remind investors that REGEN-COV received an EUA from the FDA in November 2020 for the treatment of mild-to-moderate COVID-19 in adults as well as pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.
Regeneron’s shares have gained 3.8% in the past year compared with the industry’s growth of 18.5%.
Data published earlier also showed that the REGEN-COV antibody cocktail is effective against the SARS-CoV-2 variants.
Regeneron has a collaboration agreement with Roche RHHBY (OTC:RHHBY) for REGEN-COV outside the United States.
Given the alarming levels of the spread and severity of the pandemic, quite a few pharma/biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients. The emerging new strains pose a greater threat.
Earlier, Vir Biotechnology (NASDAQ:VIR), Inc. VIR and partner GlaxoSmithKline (NYSE:GSK) plc GSK announced that an Independent Data Monitoring Committee (IDMC) has recommended that its late-stage study evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization should pause enrollment due to evidence of profound efficacy.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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