Phase III REGN-COV 2069 trial of REGN-COV2 meets endpoints in COVID-19.- Roche

Roche confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met its primary and key secondary endpoints. It showed that the subcutaneous administration of casirivimab and imdevimab reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. In addition, individuals treated with casirivimab and imdevimab who still experienced a symptomatic infection resolved their symptoms on average within one week, compared to three weeks with placebo. No new or serious safety signals were observed. The phase III, double-blind, placebo-controlled trial assessed the effect of casirivimab and imdevimab on individuals without SARS-CoV-2 antibodies or any COVID-19 symptoms, who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days. It included 1,505 people who were not infected with SARS-CoV-2 at baseline and received either one dose of casirivimab with imdevimab (1,200 mg) or placebo, administered as subcutaneous injections. In addition, the multi-part study evaluated the antibody cocktail in a cohort of 204 recently infected asymptomatic patients randomised to receive either one dose of casirivimab and imdevimab (1,200 mg subcutaneous administration) or placebo. In this cohort, casirivimab and imdevimab reduced the overall risk of progressing to symptomatic COVID-19 by 31%. Detailed results from the trial will be shared with regulatory authorities as soon as possible. Regeneron will share new data with the FDA and Roche and Regeneron will continue to work with the European Medicines Agency (EMA) and other health authorities across the globe.