Invivyd provides update on Phase 3 DECLARATION study of VYD2311

Invivyd (IVVD) announced progress in its REVOLUTION clinical program for VYD2311, an investigational candidate for the prevention of symptomatic COVID-19. The company conducted a pre-specified sample size re-estimation analysis for its Phase 3 DECLARATION study, which triggered an upsizing of approximately 500 additional subjects. Invivyd noted that top-line results are now expected to shift modestly to the third quarter of 2026. Additionally, the company has aligned with the FDA on an initial Pediatric Study Plan, the “DRUMMER” study, to support a potential BLA for VYD2311 in children aged 0-11 years, contingent on the success of the DECLARATION study. “We are thrilled with our progress in the DECLARATION study. Pooled, blinded COVID-19 event accumulation is already robust, and our conservative upsizing algorithm means that we can move to higher confidence in statistical power with very modest additional time. This re-sizing was designed prospectively with our rapid recruitment speed in mind and our desire for the most robust potential dataset. We have an extraordinary, high-value opportunity to change infectious disease medicine near-term,” said Marc Elia, chairman of Invivyd.