
Invivyd Kicks Off Phase 3 DECLARATION Trial for VYD2311, a Vaccine‑Alternative Antibody to Prevent COVID‑19
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Invivyd, Inc. (Nasdaq: IVVD) has announced the initiation of its pivotal Phase 3 DECLARATION clinical trial to evaluate VYD2311, an investigational monoclonal antibody designed as a vaccine alternative for COVID‑19 prevention. The randomized, triple‑blind, placebo‑controlled study aims to assess both the safety and efficacy of VYD2311 versus placebo in reducing PCR‑confirmed symptomatic COVID‑19 over a three‑month period, with potential protection extending beyond this time frame. The trial will enroll approximately 1,770 adults and adolescents, including individuals with and without risk factors for severe disease, and will compare a single intramuscular (IM) dose as well as monthly IM doses to placebo. The primary endpoint is the incidence of symptomatic COVID‑19 confirmed by PCR testing. DECLARATION is part of Invivyd’s broader REVOLUTION clinical program that seeks to establish flexible, antibody‑based prophylaxis options against COVID‑19, with top‑line data expected in mid‑2026. In earlier Phase 1/2 studies, VYD2311 was well‑tolerated at doses higher than those planned for DECLARATION, and Invivyd has already produced commercial‑scale quantities of the antibody as part of preparations for potential approval and launch.
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