Cidara Therapeutics Presents Data on CD388 from its Phase 2b NAVIGATE Trial and Preclinical Studies Against H5N1 at ISRV's 8th AVG and 3rd IMRP 2025 Meeting

Core Insights - Cidara Therapeutics presented promising efficacy and safety results for CD388, a non-vaccine influenza preventative, during the ISRV conference, highlighting its potential for long-term protection against influenza and H5N1 strains [1][2] Group 1: CD388 Efficacy and Safety - The Phase 2b NAVIGATE study involved over 5,000 healthy adults aged 18-64, randomized to receive either CD388 (150mg, 300mg, or 450mg) or placebo, demonstrating statistically significant protection against influenza illness over 24 weeks [1][3] - CD388 was well tolerated, with the primary endpoint focusing on preventative efficacy against laboratory-confirmed influenza [1][3] Group 2: Preclinical Data on H5N1 - Preclinical studies in ferrets showed that a single subcutaneous dose of CD388 at 3 mg/kg provided 75% protection against lethal H5N1 infection, while a 10 mg/kg dose resulted in 100% survival [3] - CD388-treated ferrets exhibited reduced weight loss and clinical symptoms compared to untreated controls, indicating its potential effectiveness against highly pathogenic strains [3] Group 3: Future Plans and Presentations - Cidara plans to disclose additional safety, pharmacokinetics, and virology data from the Phase 2b NAVIGATE study at upcoming conferences [2] - The company will host a lunch symposium at the conference to discuss CD388's broad influenza protection capabilities [5]