Cidara Therapeutics (CDTX) has reached target enrollment in its Phase 3 ANCHOR trial of 6,000 participants across clinical trial sites in the US and UK. The trial is designed to evaluate the safety and efficacy of CD388, a non-vaccine preventative of seasonal influenza, in populations at high-risk for complications of influenza. These populations include individuals who are immune compromised, have certain comorbidities, or are over 65 years of age. ANCHOR is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of CD388 administered as a one-time 450-milligram subcutaneous dose in adults and adolescents. The study will include an interim analysis in the first quarter of 2026 to assess the trial size and powering assumptions and determine the potential need for enrollment during the Southern Hemisphere flu season. Results from this single Phase 3 trial, if successful, are expected to be sufficient for potential BLA approval in the high-risk populations represented in the Phase 3 trial.
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