Invivyd announces results from CANOPY Phase 3 trial

Invivyd (IVVD) announced that results from its CANOPY Phase 3 clinical trial of pemivibart have been published online as an Advance Article in the peer-reviewed journal Clinical Infectious Diseases, CID. The publication, titled “Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial” highlights attractive safety, substantial clinical antiviral activity, the immunobridge between calculated serum virus neutralizing antibody titers and pemivibart and historical clinical efficacy data, and nominally statistically significant and clinically meaningful efficacy of pemivibart versus placebo in a contemporary U.S. population facing, immune-evasive Omicron SARS-CoV-2 viruses. Pemivibart demonstrated strong protection from symptomatic COVID-19 versus placebo during the 6-month on-drug period. Pemivibart was generally well-tolerated, and most treatment-emergent adverse events in both CANOPY cohorts were classified as mild/moderate in severity.