Invivyd advances Phase 3 VYD2311 program and measles antibody candidate
Invivyd reported progress in the Phase 3 DECLARATION trial of VYD2311, with top-line data now expected in Q3 2026 after a sample size increase of about 500 subjects. The company also aligned with the FDA on the LIBERTY Phase 3 study, a pediatric study plan for DRUMMER, and advanced measles antibody candidate VMS063.
Invivyd reported progress in the REVOLUTION clinical program for VYD2311, including the pivotal DECLARATION Phase 3 study assessing VYD2311 for pre-exposure COVID-19 prophylaxis versus placebo over 90 days. The study has accumulated approximately 50% of COVID-19 events, and a blinded sample size re-estimation triggered an upsizing of approximately 500 subjects to support statistical power. Top-line results from the DECLARATION study are now expected in the third quarter of 2026, a shift from prior guidance framed around mid-year 2026.
Earlier this month, the company said it reached alignment with the FDA on the design of LIBERTY, a Phase 3 clinical trial that will evaluate the comparative safety and immunologic profile of its investigational monoclonal antibody VYD2311 against commercially available mRNA COVID vaccines. The study will also explore the safety and immune response when VYD2311 is administered at the same time as an mRNA COVID vaccine.
The FDA, providing joint feedback from its drug and biologics centers, requested specific monitoring of adverse events of special interest associated with mRNA COVID vaccines in the LIBERTY trial. The agency cited the known risk of myocarditis and pericarditis, particularly in young adults following mRNA COVID vaccination. The company said no similar monitoring requests have been made for its other clinical trials that do not include an mRNA vaccine arm, and that myocarditis and pericarditis have not been observed in any Invivyd clinical trials to date, nor in postmarketing adverse event reports for Pemivibart.
The company also aligned with the U.S. FDA on an initial Pediatric Study Plan for the DRUMMER pediatric immunobridging and safety trial of VYD2311 in children aged 0 to 11 years. The trial is planned to proceed only if the DECLARATION study is successful.
Invivyd also announced the discovery of VMS063, a half-life-extended monoclonal antibody candidate targeting the measles Fusion protein. Potential use cases include treatment of symptomatic measles, outbreak prophylaxis, and early childhood passive protection, with a target for IND readiness in late 2026.
In its 10-K for the period ending Dec. 31, 2025, auditor PricewaterhouseCoopers LLP issued an unqualified opinion that included doubt about the company’s ability to continue as a going concern.