Invivyd, Inc. announced positive exploratory clinical efficacy data from the ongoing CANOPY Phase 3 clinical trial of Pemivibart, a half-life extended investigational monoclonal antibody, for the pre-exposure prophylaxis of COVID-19. The data indicates a sustained protection against COVID-19 over a 12-month period following initial dosing.
Sustained Efficacy Over 12 Months
During the follow-up months 7-12 in CANOPY Cohort B, the Pemivibart arm exhibited a 64% relative risk reduction compared to the placebo group. This continued protection, even without ongoing dosing, was a pre-specified exploratory endpoint. Combined with initial 180-day clinical efficacy observations, this resulted in an overall 12-month protection rate of 76% after two doses of Pemivibart.
Safety Profile
The safety profile of Pemivibart remained consistent throughout the 12-month study period, with no new trends or safety signals identified. This is an important consideration for prophylactic treatments, where long-term safety is paramount.
Financial Impact and Regulatory Considerations
Invivyd estimates Pemgarda net product revenue of $9.3 million for the third quarter. However, the company withdrew its previous guidance of $150-200 million in Pemgarda net product revenue for fiscal year 2024. This decision follows a late-Q3 2024 warning from the U.S. FDA regarding the potential for substantially reduced activity of Pemivibart, as communicated through the Pemgarda Fact Sheet. This regulatory hurdle presents a challenge to the commercial outlook for Pemgarda.
