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Investing.com -- Cidara Therapeutics Inc (NASDAQ:CDTX) stock surged 90.1% following the announcement of positive topline results from its Phase 2b NAVIGATE trial evaluating CD388 for seasonal influenza prevention.
The biotechnology company reported that the study met its primary endpoint, demonstrating statistically significant prevention efficacy across all three dose groups tested. The trial evaluated CD388, a drug-Fc conjugate therapeutic developed using Cidara’s Cloudbreak platform, in healthy unvaccinated adults aged 18 to 64.
The highest dose group (450 mg) showed 76.1% prevention efficacy against laboratory and clinically confirmed influenza over 24 weeks, while the 300 mg and 150 mg doses demonstrated 61.3% and 57.7% efficacy, respectively. All results were statistically significant compared to placebo.
The study also met all secondary endpoints, including efficacy at different temperature thresholds and maintenance of prevention efficacy up to 28 weeks. Safety data showed similar profiles across all treatment arms with no safety signals observed.
"Results such as these are unprecedented in influenza and support our confidence in the potential of CD388 to offer robust, once-per-season protection against influenza A and B," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
CD388 is designed to provide seasonal protection against all influenza strains regardless of immune status. The company has submitted an end of Phase 2 meeting request to the FDA to discuss Phase 3 trial design and expects to present additional results at scientific conferences in 2025.
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