
Invivyd Kicks Off PhaseâŊ3 DECLARATION Trial for VYD2311, a VaccineâAlternative Antibody to Prevent COVIDâ19
âĒBy ADMIN
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Invivyd, Inc. (Nasdaq:âŊIVVD) has announced the initiation of its pivotal PhaseâŊ3 DECLARATION clinical trial to evaluate VYD2311, an investigational monoclonal antibody designed as a vaccine alternative for COVIDâ19 prevention. The randomized, tripleâblind, placeboâcontrolled study aims to assess both the safety and efficacy of VYD2311 versus placebo in reducing PCRâconfirmed symptomatic COVIDâ19 over a threeâmonth 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 COVIDâ19 confirmed by PCR testing. DECLARATION is part of Invivydâs broader REVOLUTION clinical program that seeks to establish flexible, antibodyâbased prophylaxis options against COVIDâ19, with topâline data expected in midâ2026. In earlier PhaseâŊ1/2 studies, VYD2311 was wellâtolerated at doses higher than those planned for DECLARATION, and Invivyd has already produced commercialâscale quantities of the antibody as part of preparations for potential approval and launch.
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