Invivyd finishes late-stage enrollment for upsized covid antibody study

Invivyd (NASDAQ:IVVD) completed enrollment for the pivotal Phase 3 clinical trial of its leading monoclonal antibody candidate, positioning the biotechnology firm to deliver late-stage results later this quarter.

The company finalized the recruitment window for its upsized DECLARATION study, which evaluates the efficacy and safety of the investigational antibody VYD2311 in preventing symptomatic Covid-19.

The randomized, placebo-controlled trial serves as the core data foundation to support a planned Biologics License Application submission to federal regulators for use in a broad population including adults and adolescents.

With enrollment concluded, top-line data updates remain on track for approximately late Q3 2026.

The enrollment milestone follows a strategic expansion of the trial's target population.

Invivyd previously executed a pre-specified sample size re-estimation analysis to shield the study against natural fluctuations in community viral transmission rates.

The resulting protocol modification triggered an expansion of the cohort, adding roughly 500 additional subjects to increase the overall statistical power of the efficacy readout.

The trial architecture tests two separate delivery regimens against a placebo control.

One arm assesses a single intramuscular injection designed to establish baseline protection, while a secondary arm measures monthly intramuscular doses.

The dual-track approach seeks to validate the safety and efficacy of more frequent dosing to support individual choice for at-risk populations seeking extra periodic protection.