Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

AstraZeneca’s Phase III Covid-19 antibody trial meets primary endpoints

AstraZeneca reported successful results from its Phase III SUPERNOVA trial, evaluating sipavibart's efficacy in preventing Covid-19 among immunocompromised individuals. Sipavibart, a long-acting antibody, was assessed for Covid-19 pre-exposure prophylaxis. Licensed from RQ Biotechnology in May 2022, it showed promise in reducing symptomatic Covid-19 occurrences. The global, double-blind, placebo-controlled trial spanned 197 sites across the US, UK, EU, and Asia, comparing sipavibart to control (tixagevimab / cilgavimab or placebo). Subjects aged 12 and above received a 300mg intramuscular dose, followed by a second dose approximately six months later. The findings revealed a significant decline in symptomatic Covid-19 cases and reductions in infections from variants lacking the F456L mutation. The trial met both primary endpoints including the relative symptomatic disease risk reduction and the reduction of infections caused by variants not containing the F456L mutation.

Notably, SUPERNOVA stands as the sole large Phase III trial providing efficacy data in immunocompromised patients against recent variants, with well-tolerated treatment and balanced adverse events between groups.