SABS - SAB Biotherapeutics replaces comparator drug with placebo in COVID drug phase 3 trial

SAB Biotherapeutics (NASDAQ:SABS) updated the design of its ongoing phase 3 ACTIV-2 trial evaluating SAB-185 to treat people with mild-moderate COVID infections at higher risk for progression to hospitalization. The Phase 3 trial had been designed as non-inferiority study comparing SAB-185 to an active comparator—a monoclonal antibody cocktail (casirivimab and imdevimab) authorized for treatment of COVID-19. The company said that going forward, the active comparator will be replaced with a placebo. “We welcome the fast action to modify the ACTIV-2 Phase 3 trial once it became clear that the active comparator was not effective against the Omicron variant, which now represents about 95% of new COVID-19 cases in the US,” said SAB Co-Founder, President, and CEO Eddie Sullivan. The trial is sponsored by the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health in collaboration with the AIDS Clinical Trials Group. “SAB-185 is designed to

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SAB Biotherapeutics replaces comparator drug with placebo in COVID drug phase 3 trial