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Regeneron Reports Positive Interim Data with REGEN-COV™ Antibody Cocktail used as Passive Vaccine to Prevent COVID-19
TARRYTOWN, N.Y., Jan. 26, 2021 /PRNewswire/ -- Reduction in overall infections seen within first week, with 100% prevention of symptomatic infections
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"\n TARRYTOWN, N.Y., Jan. 26, 2021 /PRNewswire/ -- \nReduction in overall infections seen within first week, with 100% prevention of symptomatic infections \nMarkedly decreased levels and duration of viral shedding in asymptomatic infections that still occurred in REGEN-COV group \nConfirmatory Phase 3 results expected early in second quarter \nPotential application in people who need immediate protection or respond poorly to vaccination \nREGEN-COV 1,200 mg administered by subcutaneous injection, providing greater convenience and efficiency than infusion\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive initial results from an ongoing Phase 3 clinical trial evaluating REGEN-COV™ (casirivimab and imdevimab antibody cocktail) used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection (due to household exposure to a COVID-19 patient). The trial is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).\nAn exploratory analysis was conducted on the first approximately 400 evaluable individuals enrolled in the trial, who were randomized to receive passive vaccination with REGEN-COV (1,200 mg via subcutaneous injections) or placebo. Results included: \nPassive vaccination with REGEN-COV resulted in 100% prevention of symptomatic infection (8/223 placebo vs. 0/186 REGEN-COV), and approximately 50% lower overall rates of infection (symptomatic and asymptomatic) (23/223 placebo vs. 10/186 REGEN-COV). The lower number of infections occurring with REGEN-COV therapy were all asymptomatic, with decreased peak virus levels and short duration of viral shedding. Infections occurring in the placebo group had, on average, more than 100-fold higher peak viral load. Infections in the REGEN-COV group lasted no more than 1 week, while approximately 40% of infections in the placebo group lasted 3-4 weeks. No infected individuals in the REGEN-COV group had high viral loads (>10^4 copies/mL) compared to 62% of the infected placebo group (13/21 placebo vs. 0/9 REGEN-COV).REGEN-COV was associated with lower disease burden: Fewer total viral shedding weeks (44 weeks placebo vs. 9 weeks REGEN-COV). Fewer total high viral shedding weeks (>10^4 copies/mL) (22 weeks placebo vs. 0 weeks REGEN-COV). Fewer total symptomatic w...