Cidara Therapeutics Announces Expanded and Accelerated Phase 3 Plan for CD388, a Non-Vaccine Preventative of Seasonal Influenza

Core Insights - Cidara Therapeutics is advancing its Phase 3 trial for CD388 following FDA feedback, expanding the study population to include adults over 65 years and increasing the potential patient pool from approximately 50 million to over 100 million in the U.S. [1][2][3] Group 1: Phase 3 Study Details - The Phase 3 study will be a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating a single 450-milligram dose of CD388 administered subcutaneously at the start of the flu season [2][3] - Enrollment is set to begin by the end of September 2025 in the Northern Hemisphere, with a target of 6,000 subjects, representing a six-month acceleration from the previous timeline [2][6] - An interim analysis will be conducted after the Northern Hemisphere flu season to assess trial size and enrollment for the Southern Hemisphere [2][3] Group 2: Company Background and Product Information - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with CD388 being a long-acting antiviral aimed at universal prevention of influenza [4] - CD388 received Fast Track Designation from the FDA in June 2023, and positive results from the Phase 2b NAVIGATE trial were announced in June 2025 [4] - The company is also developing additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors [4]