Invivyd announces 12-month exploratory data from CANOPY Phase 3 trial

Invivyd (IVVD) announced positive 12-month exploratory clinical efficacy data from the company’s ongoing CANOPY Phase 3 clinical trial of pemivibart, a half-life extended investigational monoclonal antibody, for the pre-exposure prophylaxis, PrEP, of COVID-19. The exploratory clinical efficacy data from follow-up months 7-12 in CANOPY Cohort B showed a relative risk reduction of 64% in the pemivibart arm compared to placebo in the likelihood of trial participants contracting confirmed symptomatic COVID-19. Continued protection over this follow-up period, absent continued dosing, was a prespecified exploratory endpoint and, added to initial 180-day clinical efficacy observations, generated an overall 12-month protection rate of 76% following two doses of pemivibart. The safety profile of pemivibart over the 12-month study period was reassuring with no new trends or safety signals observed for treatment-emergent adverse events or infusion-related reactions or hypersensitivity reactions since the disclosure of the 6-month CANOPY data.