StockWatch
·
Biotechnology: Biological Products (No Diagnostic Substances)
Company UpdateApr 9, 2026, 07:21 AM

Invivyd's VYD2311 Phase 3 DECLARATION Study Achieves Sufficient Statistical Power at ~50% Progress; Advances Novel Measles mAb VMS063 into Clinical Development

AI Summary

Invivyd, Inc. announced significant progress in its REVOLUTION program, with the ongoing Phase 3 DECLARATION study for VYD2311, an investigational COVID-19 pre-exposure prophylaxis, demonstrating sufficient statistical power for high-end efficacy at approximately 50% study completion. A pre-specified sample size re-estimation analysis, conducted after 1,500 of 1,818 enrolled patients reached Day 45, confirmed the study is well-powered to meet its primary endpoint. Concurrently, the company is advancing VMS063, a novel, potential first- and best-in-class monoclonal antibody candidate for the treatment and prevention of measles, into clinical development, supported by potent preclinical neutralization and protection data. These developments underscore Invivyd's commitment to addressing critical infectious disease needs and expanding its pipeline, with further updates on the REVOLUTION program and VYD2311 data expected later in 2026.

Key Highlights

  • The Phase 3 DECLARATION study for VYD2311, an investigational COVID-19 PrEP, has accumulated sufficient confirmed, pooled, blinded COVID-19 events at approximately 50% study progress to provide statistical power for the high end of anticipated VYD2311 efficacy.
  • A pre-specified sample size re-estimation analysis was conducted when 1,500 of 1,818 enrolled patients reached Day 45 of the 90-day total study period, confirming the study is well-powered for its primary endpoint.
  • Invivyd is advancing VMS063, a novel monoclonal antibody candidate for measles, into clinical development for both treatment and prevention.
  • Preclinical data for VMS063 demonstrated potent neutralization of measles virus and protection in a non-human primate model.
  • The advancement of VMS063 addresses the increasing global outbreaks of measles, a highly contagious disease.
  • Invivyd plans to provide a more comprehensive update on the REVOLUTION program and VYD2311 data later in 2026.