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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen
TARRYTOWN, N.Y., Dec. 29, 2020 /PRNewswire/ -- Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":" TARRYTOWN, N.Y., Dec. 29, 2020 /PRNewswire/ --\nPhase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation \nAs in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes\nFirst antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19 \nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis). The results passed the futility analysis (p93% via nasal cannula, simple facemask, or similar device), including 217 who were seronegative when they entered the trial and 270 who were seropositive; although seronegative patients comprised less than half of the trial population, based on placebo rates they account for approximately two-thirds of the deaths in the absence of antibody cocktail treatment. Patients were randomized to receive the antibody cocktail (either 8,000 mg high dose or 2,400 mg low dose) or placebo, in addition to standard-of-care therapies, with 67% receiving remdesivir and 74% receiving systemic corticosteroids. Similar clinical and virologic efficacy was observed for the high and low doses of the antibody cocktail.\nBoth antibody cocktail doses were well-tolerated. In the overall trial population, the incidence of serious adverse events was 21% for high dose, 20% for low dose and 24% for placebo. Infusion reactions were more common with the high dose of the antibody cocktail (2.7% high dose, 0.9% low dose, 1.4% placebo) and there were 2 discontinuations due to infusion-related reactions, both of which occurred in the high dose group. \nIn November, the Regeneron antibody cocktail was granted an Emergen...