Cidara Therapeutics Announces Positive Topline Results from its Phase 2b NAVIGATE Trial Evaluating CD388, a Non-Vaccine Preventative of Seasonal Influenza

Core Insights - Cidara Therapeutics announced positive topline results from its Phase 2b NAVIGATE trial for CD388, demonstrating significant efficacy in preventing symptomatic influenza in healthy adults [1][7] - CD388 showed protection rates of 76%, 61%, and 58% for doses of 450mg, 300mg, and 150mg respectively, compared to placebo [1][2] - The drug was well-tolerated with no safety signals observed, and an end of Phase 2 meeting request has been submitted to the FDA [1][5] Efficacy Results - The primary efficacy analysis indicated that the prevention efficacy for the 450mg group was 76.1%, 61.3% for the 300mg group, and 57.7% for the 150mg group, with p-values of <0.0001, 0.0024, and 0.0050 respectively [2][4] - Key secondary endpoints also showed significant efficacy, with the 450mg group achieving a prevention efficacy of 76.1% for participants with temperatures ≥37.8°C [3][4] Safety and Tolerability - Safety data indicated no unexpected dose-limiting treatment-emergent adverse events across all dose groups, with injection site reactions being similar to placebo [5][6] - The overall safety profile of CD388 was consistent across all treatment arms, reinforcing its potential as a well-tolerated option for influenza prevention [5][6] Future Plans - Cidara plans to present additional results from the NAVIGATE trial at scientific conferences in 2025 and is preparing for a Phase 3 trial [6][7] - The company has engaged with the FDA to discuss the Phase 2b results and the design of the upcoming Phase 3 trial [7][12] About CD388 - CD388 is a drug-Fc conjugate designed to provide long-acting protection against all strains of seasonal and pandemic influenza with a single administration [9][12] - Unlike vaccines, CD388's efficacy is not reliant on an immune response, making it suitable for individuals regardless of their immune status [9][12]