Invivyd, Inc. announced that the first participant has been dosed in the CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody, for the prevention of symptomatic COVID-19. This clinical trial is designed to rapidly generate the clinical data needed to support a potential emergency use authorization (EUA) submission for VYD222. CANOPY is expected to enroll approximately 750 participants in two cohorts (A and B) including 300 individuals who are significantly immunocompromised.

The CANOPY pivotal clinical trial is a Phase 3 clinical trial designed to evaluate protection against symptomatic COVID-19 after receiving VYD222. The safety, tolerability, pharmacokinetic profile, and immunogenicity of VYD222 will also be evaluated. The clinical trial is expected to enroll approximately 750 participants in two cohorts (A and B) running in parallel across multiple trial sites in the U.S. Cohort A is expected to enroll approximately 300 participants who are significantly immunocompromised.

For this cohort, the company will use serum neutralizing titers against relevant SARS-CoV-2 variants at Day 28 as the primary efficacy endpoint. The primary efficacy analysis will use an immunobridging approach comparing data obtained in the CANOPY clinical trial to certain historical data from the company?s previous Phase 2/3 clinical trial of adintrevimab for the prevention of symptomatic COVID-19, in which serum neutralizing titers correlated with observed clinical efficacy. All Cohort A participants will receive VYD222 administered via intravenous (IV) infusion.

Cohort B will enroll approximately 450 participants at risk of exposure to SARS-CoV-2. The primary endpoint is safety and tolerability. Cohort B participants will be randomized 2:1 to receive VYD222 or placebo administered via IV infusion. Invivyd is evaluating the 4500 mg dose of VYD222 in the CANOPY trial.

The company expects to have initial primary endpoint data by late 2023 or early first quarter of 2024.