Invivyd Announces U.S. IND Clearance and Alignment with U.S. FDA on Pivotal Clinical Program for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID

• The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clinical trials are expected to begin around year-end 2025; top-line data anticipated mid-2026
  
• DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate prevention of COVID, at three months, from a single intramuscular (IM) dose of VYD2311, with longer-term protection anticipated. A second VYD2311 arm will evaluate monthly IM doses to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk persons wish periodic extra protection. Total expected enrollment of ~2,000 people
  
• LIBERTY is a randomized, active-controlled safety and tolerability clinical trial of VYD2311 versus mRNA-based COVID vaccine with a co-administration arm exploring VYD2311 / vaccine combination; final alignment with the FDA on combination design with vaccination expected shortly. Total expected enrollment of ~300 people
  
• DECLARATION and LIBERTY clinical trials to be funded by Invivyd’s recent capital raise; commercial launch quantities of VYD2311 are at-the-ready
  
• Details on DECLARATION and LIBERTY clinical trials, and further areas of potential post-approval research in Invivyd’s broader REVOLUTION program, will be shared in a public investor event later this month
  

NEW HAVEN, Conn., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application and provided feedback to advance the company’s REVOLUTION clinical program, Invivyd’s development program for VYD2311, a vaccine alternative monoclonal antibody candidate for the prevention of COVID.

The DECLARATION clinical trial is the company’s Biologics License Application (BLA)-enabling, Phase 3 pivotal clinical trial evaluating VYD2311 safety and prevention of COVID versus placebo. The LIBERTY clinical trial will assess the safety and tolerability of VYD2311 in a head-to-head clinical trial against mRNA-based COVID vaccine, as well as evaluate co-administration of VYD2311 with vaccination, subject to final alignment with the FDA. Together, these two clinical trials are designed to provide robust, medical practice-changing information to regulators, populations at risk for COVID, and policy makers seeking high-quality, safe, non-vaccine protection from COVID. Invivyd intends to initiate these clinical trials as soon as practicable, with the goal of year-end 2025 trial start and top-line data mid-2026. Additional studies in the REVOLUTION program may be contemplated for conduct post-approval of VYD2311, if a BLA is granted by the FDA, to further elaborate the profile of antibody prevention of COVID.