Core Insights - Cidara Therapeutics has initiated the Phase 2b NAVIGATE trial to assess the efficacy and safety of CD388 for pre-exposure prophylaxis of influenza during the current flu season [1][2] - CD388 is designed to provide universal protection against all known strains of seasonal and pandemic influenza, functioning independently of the immune response [3][4] Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak® platform to develop drug-Fc conjugates (DFCs) aimed at improving treatment for serious diseases [1][5] - The lead DFC candidate, CD388, is a long-acting antiviral that can potentially offer season-long protection against influenza with a single administration [4][5] - CD388 received Fast Track Designation from the FDA in June 2023, and the company plans to advance it into a Phase 2b trial during the 2024 Northern Hemisphere influenza season [5] Clinical Trial Details - The Phase 2b NAVIGATE trial is a randomized, double-blind, controlled study involving 5,000 healthy unvaccinated adults, comparing three dose groups of CD388 against a placebo [2] - Participants will be monitored throughout the influenza season for breakthrough cases, with a focus on laboratory and clinically confirmed influenza rates [2] Product Characteristics - CD388 is a drug-Fc conjugate that combines a potent small molecule neuraminidase inhibitor with a proprietary Fc fragment of a human antibody, designed for long-acting inhibition of viral proliferation [4] - Unlike traditional vaccines, CD388's efficacy does not depend on an immune response, making it suitable for individuals with varying immune statuses [3][4]
Cidara Therapeutics Announces First Subjects Dosed in Phase 2b NAVIGATE Trial Evaluating CD388 for the Prevention of Seasonal Influenza