Cidara Therapeutics, Inc. announced on June 23, 2025, positive topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza. The study met its primary and all secondary efficacy endpoints.
Single doses of CD388 at 450mg, 300mg, and 150mg conferred 76%, 61%, and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo. The study also demonstrated maintenance of prevention efficacy up to 28 weeks with statistical significance.
CD388 was well-tolerated across all dose groups, with no unexpected dose-limiting treatment-emergent adverse events observed. Cidara has submitted an End of Phase 2 meeting request to the U.S. Food and Drug Administration (FDA) to review these results and discuss the Phase 3 trial design and start time.
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