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Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company applying its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced it presented late-breaking Phase 2b clinical data on its non-vaccine influenza preventative candidate, CD388, during ID Week 2025, taking place October 19-22, 2025, in Atlanta, GA.
"We are pleased to share additional data from our Phase 2b NAVIGATE study at ID Week which further validates CD388 as a potential once per season influenza preventative option," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "These recent safety and efficacy results showcase CD388's potential to offer up to 76.1% prevention efficacy against influenza A and B in healthy, unvaccinated adults. The new virology data presented further reinforces our dose selection for our ongoing Phase 3 ANCHOR study, which aims to evaluate CD388 in individuals with immune compromised conditions, high-risk co-morbidities, or those over the age of 65."
Presentation Title: A Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of CD388, a Novel Drug-Fc-Conjugate, for Prevention of Illness due to Influenza A and B in Healthy Unvaccinated Participants
Presenter: James Alexander MD, MPH, FIDSA
Session: Extra, Extra! New Info on Treating and Preventing RSV and Influenza
Session Location: B401-B402
Session Date and Time: Monday, October 20, 2025, 3:15 PM - 4:30 PM ET
Summary: CD388's safety and prevention efficacy (PE) against influenza A and B in healthy, unvaccinated adults were evaluated in a double-blind, randomized, placebo-controlled, Phase 2b study. Each CD388 dose tested provided significant PE versus placebo: 57.7% (150 mg of CD388), 61.3% (300 mg of CD388), and 76.1% (450 mg of CD388). CD388 was well tolerated with no apparent safety issues. The results suggested that a single dose of CD388 could have the potential to provide season-long prevention of influenza illness in individuals not adequately protected by available influenza vaccines.
Posted In: CDTX
