Regeneron (REGN) Posts Positive Data on COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals, Inc. REGN announced positive data from a late-stage study (2069B) of recently infected asymptomatic COVID-19 patients, which is evaluating the antibody cocktail REGEN-COV (casirivimab with imdevimab) 1,200 mg administered via subcutaneous (SC) administration.
The phase III study enrolled 204 individuals without any COVID-19 symptoms who tested positive for SARS-CoV-2 but did not have anti-virus antibodies at baseline and were randomized to receive either 1 dose of REGEN-COV (1,200 mg) or placebo.
The cocktail reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day. Data also showed that REGEN-COV shortened symptom duration and markedly reduced viral levels. The study met all primary and key secondary endpoints. Moreover, the total number of weeks for which patients experienced symptoms was nearly cut in half (45%) with REGEN-COV, and the viral burden was reduced by more than 90%.
Separately, Regeneron also announced that the phase III study (2069A) evaluating the ability of REGEN-COV to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals met its primary and key secondary endpoints. The phase III double-blind, placebo-controlled trial evaluated the effect of REGEN-COV on uninfected individuals without anti-SARS-CoV-2 antibodies or any COVID-19 symptoms, who lived in the same household where an individual has tested positive for SARS-CoV-2 within the prior four days. The study enrolled 1,505 people who were not infected with SARS-CoV-2 at baseline and randomized to receive either 1 dose of REGEN-COV (1,200 mg) or placebo, administered as SC injections.
Results of the study showed that REGEN-COV 1,200 mg administered SC reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. REGEN-COV rapidly protected household contacts from exposure to SARS-CoV-2 at home, with 72% protection against symptomatic infections in the first week and 93% in subsequent weeks.
We remind investors that REGEN-COV has been granted Emergency Use Authorization by the FDA to treat 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 now plans to share these encouraging data with the FDA and request an EUA expansion to include COVID prevention for appropriate populations, using a 1,200 mg subcutaneous dose.
Earlier, the company announced that its phase III outcomes trial on REGEN-COV (casirivimab with imdevimab) in high-risk non-hospitalized COVID-19 patients was successful.
Regeneron’s shares have lost 1.6% in the year so far compared with the industry’s decline of 6.8%.
It has a collaboration agreement with Roche 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, Inc. VIR and partner GlaxoSmithKline plc GSK submitted an application to the FDA requesting an EUA for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
Roche Holding AG (RHHBY): Get Free Report
GlaxoSmithKline plc (GSK): Free Stock Analysis Report
Vir Biotechnology, Inc. (VIR): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.