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Invivyd Announces Dosing of First Participant in CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of Symptomatic COVID-19
Initial primary endpoint data anticipated in late 2023 or early Q1 2024 WALTHAM, Mass., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a
About this update from Invivyd, Inc.
[{"type":"text","content":"Initial primary endpoint data anticipated in late 2023 or early Q1 2024 \nWALTHAM, Mass., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today 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 initiation of the CANOPY pivotal clinical trial marks a major milestone for Invivyd, and it is a significant step in our journey to rapidly advance VYD222 toward a potential EUA submission,” said Dave Hering, Chief Executive Officer of Invivyd. “Thanks to the hard work and dedication of our teams, Invivyd is at the forefront of advancing new therapeutics to address circulating viral threats. With our proprietary database of potentially eligible individuals and a Day 28 primary efficacy endpoint in the immunocompromised cohort, we expect CANOPY to enroll quickly, and we remain on track to have initial primary endpoint data around year end.” Commenting on the milestone, Pete Schmidt, M.D., M.Sc., Chief Medical Officer at Invivyd added, “In recent months we have seen both the number of COVID-19 cases and disease related hospitalizations increase at an alarming rate in vulnerable populations. It is clear COVID-19 is going to remain a major global health concern for the foreseeable future, and this increase comes at a time when immunocompromised individuals have limited options for the prevention of symptomatic COVID-19. It is this urgent public health need that drives us to advance important new therapeutics like VYD222 as quickly as possible.” About CANOPY 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 t...