Segal Trials announced on July 7, 2025, its participation in the successful Phase 2b NAVIGATE clinical trial conducted by Cidara Therapeutics, evaluating CD388 for the prevention of seasonal influenza. Dr. Steven Chavoustie served as the Principal Investigator for the study at Segal Trials.
The NAVIGATE trial, which enrolled over 5,000 healthy, unvaccinated adults, met both its primary and secondary efficacy endpoints. Single doses of CD388 conferred 76%, 61%, and 58% protection across three dosage levels, respectively, from symptomatic influenza over a 24-week period.
CD388 was well-tolerated at all doses with no unexpected safety signals reported. Following the trial's success, Cidara Therapeutics has submitted an End of Phase 2 meeting request to the U.S. Food and Drug Administration (FDA) to discuss the upcoming Phase 3 trial design, marking a potential paradigm shift in flu prevention.
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