Phase III trial of REGEN-COV™ (casirivimab with imdevimab) antibody cocktail reports reduction in hospitalization or death in non-hospitalised COVID-19 Patients

RCT (n=4,567) met its primary endpoint, showing significant reduction in risk of hospitalization or death through day 29 (occurred in 7 [1.0%] on 1200 mg vs 24 [3.2%] placebo; p=0.0024 and 18 [1.3%] on 2400mg vs 62 [4.6%] placebo, p<0.0001).

SPS commentary:

REGEN-COV is a cocktail of two monoclonal antibodies that bind non-competitively to the critical receptor binding domain of the virus's spike protein.  Under an Emergency Use Authorization (EUA) issued by the FDA, REGEN-COV is currently available in the U.S. to treat mild-to-moderate COVID-19 in adults, as well as in paediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalisation. It is currently available in a 2400 mg IV dose. The company is planning to submit these new data requesting that a lower 1200 mg dose be added to EUA. The FDA recently updated U.S. EUA fact sheets for all authorized monoclonal antibody treatments, indicating that REGEN-COV is the only one to retain potency against key emerging variants

Biospace Inc.