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Phase 3 Treatment Trial in Recently Infected Asymptomatic Patients Showed REGEN-COV™ (casirivimab with imdevimab) Significantly Reduced Progression to Symptomatic COVID-19
TARRYTOWN, N.Y., April 12, 2021 /PRNewswire/ -- Second Phase 3 trial undertaken in collaboration with NIAID to announce results today, both using subcutaneous
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y., April 12, 2021 /PRNewswire/ --\nSecond Phase 3 trial undertaken in collaboration with NIAID to announce results today, both using subcutaneous administration of REGEN-COV in asymptomatic individuals without prior COVID-19 infection\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from a Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV™ (casirivimab with imdevimab) 1,200 mg administered via subcutaneous (SC) administration. REGEN-COV reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day. The trial also demonstrated that REGEN-COV shortened symptom duration and markedly reduced viral levels.\nThe Phase 3 trial is the second to report results today, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The trial 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. \n\"COVID-19 transmission often occurs via infected people who do not yet have symptoms, so it is critical that we rapidly diagnose and treat these individuals for their own health and to prevent transmission,\" said Katharine Bar, M.D., co-principal investigator of the trial and Assistant Professor of Medicine, Infectious Diseases, Hospital of the University of Pennsylvania. \"These data pave the way for REGEN-COV to be used before patients become symptomatic, with a more convenient subcutaneous administration.\"\nThe trial met all primary and key secondary endpoints. In addition to reducing the risk of symptomatic infections, the total number of weeks patients experienced symptoms was nearly cut in half (45%) with REGEN-COV, and the viral burden was reduced by more than 90%. While not included in the initial analysis plan, researchers also found that 0 REGEN-COV patients and 6 placebo patients were either hospitalized or visited the emergency room because of COVID-19 during the 29-day efficacy assessment period.\nThe data build on previously announced results from the Phase 3 outcomes (2067) and Phase 2 virology (20145) trials in non-hospitalized COVID-19 pa...