Core Insights - Cidara Therapeutics has initiated a Phase 3 trial for CD388, a non-vaccine preventative for seasonal influenza targeting high-risk populations [1][2] - The trial will enroll 6,000 participants, including adults over 65 and those with high-risk co-morbidities [1] - CD388 has shown positive results in a previous Phase 2b trial, indicating its potential as a significant preventative option for influenza [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with CD388 being the lead candidate [4] - CD388 is designed to provide long-acting antiviral protection against seasonal and pandemic influenza with a single dose [4] - The company had over $500 million in cash as of the end of Q2 2025, sufficient to fund the Phase 3 program through completion [2] Trial Details - The Phase 3 trial, named ANCHOR, is a global, multicenter, randomized, double-blind, placebo-controlled study [2] - Participants will receive a one-time 450-milligram subcutaneous dose of CD388, with a minimum of 10% being immune-compromised [2] - An interim analysis will be conducted after the Northern Hemisphere flu season to assess trial size and enrollment for the Southern Hemisphere [2]
Cidara Therapeutics Announces First Participants Dosed in Phase 3 ANCHOR Trial Evaluating CD388 for the Prevention of Seasonal Influenza in High-Risk Populations