AN2 Therapeutics submits amended EBO-301 trial statistical analysis plan to FDA

AN2 Therapeutics (ANTX) announced its submission of an amended statistical analysis plan to the FDA selecting the Quality of Life – Bronchiectasis respiratory domain patient reported outcome instrument as the primary efficacy endpoint for the Phase 3 part of the EBO-301 trial. The company will evaluate whether the Phase 3 data supports the Phase 2 findings, where potential clinical proof-of-concept was shown. The company plans to review both Phase 2 and Phase 3 results with the FDA and discuss potential registrational pathways. Based on the results of the Phase 2 study, the company has updated the Phase 3 portion of the statistical analysis plan to designate the QOL-B respiratory domain PRO score change from baseline to treatment at month six as the primary Phase 3 endpoint. The company believes that this approach aligns with current FDA Guidance for Industry on NTM drug development regarding the use of a clinical outcome measure as the sole primary endpoint and, it also follows the precedent established by Insmed’s confirmatory study of Arikayce in treatment-naive MAC patients, where the same QOL-B instrument has been reported as the primary efficacy measure. The company intends to release topline Phase 3 results in the second quarter of 2025, subject to the timing of any potential FDA response.