Invivyd Completes Enrollment In DECLARATION Phase 3 Trial of VYD2311 To Prevent Symptomatic Covid-19; Top-line Data Expected In Approximately Late Q3 2026
DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of symptomatic COVID-19 versus placebo, at three months, from a single intramuscular (IM) dose, with protection beyond three months anticipated
A second arm is evaluating monthly IM doses of VYD2311 versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk people seek periodic extra protection from COVID
Invivyd previously conducted a pre-specified sample size re-estimation analysis designed to add statistical power robustness given future COVID event rate variability; upsizing was triggered and added ~500 additional subjects
Rapid enrollment of upsized cohort leaves top-line results on track for approximately late Q3 2026
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