Invivyd Initiates Pivotal Phase 3 DECLARATION Trial for VYD2311, a BLA-Enabling Vaccine-Alternative Antibody for COVID-19 Prevention
Invivyd, Inc. (IVVD) announced on December 23, 2025, the initiation of its pivotal DECLARATION clinical trial, a Phase 3 study designed to evaluate the efficacy and safety of VYD2311, an investigational vaccine-alternative monoclonal antibody candidate, in preventing symptomatic COVID-19. This milestone marks a significant step in the company’s efforts to provide new prophylactic options against the persistent viral threat.
Pivotal Trial Status and Regulatory Pathway
The DECLARATION trial is structured as a Biologics License Application (BLA)-enabling study, meaning successful results could pave the way for VYD2311’s submission for full regulatory approval. The trial is designed as a randomized, triple-blind, placebo-controlled study, considered the gold standard for clinical evidence, to assess VYD2311’s ability to prevent symptomatic COVID-19 infection.
The study targets a broad population, encompassing both adults and adolescents, reflecting the need for effective prophylactic interventions across various age groups susceptible to the virus. The initiation of DECLARATION follows the U.S. Food and Drug Administration (FDA) clearance of Invivyd's Investigational New Drug (IND) application for VYD2311.
The DECLARATION trial is the company's BLA-enabling, Phase 3 randomized, triple-blind, placebo-controlled clinical trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents.
The REVOLUTION Program and Pipeline Expansion
The DECLARATION trial is one of two pivotal studies launched under Invivyd’s comprehensive REVOLUTION program. The FDA’s clearance of the IND application allowed the company to launch both DECLARATION and the LIBERTY trial, both of which are Phase 3 studies expected to generate top-line data crucial for regulatory filings.
VYD2311 is positioned as a vaccine-alternative antibody. While vaccines stimulate the body's immune system to produce its own antibodies, monoclonal antibodies like VYD2311 provide immediate, passive immunity, which is particularly critical for immunocompromised individuals or those who do not respond adequately to traditional vaccination.
Broader Portfolio Focus
Beyond the REVOLUTION program, Invivyd is actively engaged in other clinical trials focused on both the prevention and treatment of COVID-19. The company is also investing in its early-stage pipeline, which includes discovery stage candidates aimed at preventing other respiratory illnesses, such as seasonal influenza, in addition to next-generation COVID-19 prophylactic treatments.
The progression of VYD2311 into a BLA-enabling Phase 3 trial underscores the ongoing pharmaceutical commitment to developing durable, non-vaccine interventions against SARS-CoV-2, ensuring that the medical community has multiple tools available to manage the virus as it continues to evolve.
