Regeneron Pharmaceuticals, Inc. REGN announced encouraging initial data from an ongoing phase I/II/III study of its antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen.
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
The analysis was prospectively designed to focus on patients who had not yet developed their own immune response to SARS-CoV-2 (i.e., did not have antibodies at baseline: seronegative).
The main reason for this initial analysis was to determine if there was sufficient efficacy in these patients to warrant the continuation of the trial (i.e., futility analysis).
The results passed the futility analysis as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation.
Based on a post-hoc analysis, the risk of death or receiving mechanical ventilation was reduced by approximately half with the antibody cocktail treatment starting one-week post-treatment. In seronegative patients, the antibody cocktail reduced the time-weighted average daily viral load through day 7 by -0.54 log10 copies/mL and through day 11 by -0.63 log10 copies/mL.
While these preliminary data are encouraging, the clinical efficacy data are based on a small data set of events and a much larger study will be needed to characterize this effect. Regeneron believes that data from the ongoing U.K.-based RECOVERY study will be more conclusive. This trial continues to recruit all hospitalized patients regardless of the degree of severity, based on a recommendation from its Independent Data Monitoring Committee.
We remind investors that the antibody cocktail was granted an Emergency Use Authorization (EUA) by the FDA in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.
Regeneron’s shares have rallied 29% in the year so far compared with the industry’s growth of 7.4%.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to come up with treatments and vaccines to cure the infected and prevent the contagion. 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 FDA grants EUA to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available.
Last month, Eli Lilly and Company LLY and partner Incyte INCY too announced that the FDA has issued an EUA for the distribution and emergency use of baricitinib to be used in combination with Gilead’s GILD remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory-confirmed COVID-19, who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
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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