BiomX Provides Update on BX004 Phase 2b Trial in Cystic Fibrosis

Core Insights - BiomX Inc. is addressing FDA follow-up information requests to lift the clinical hold on the nebulizer device used in the Phase 2b trial of BX004 for cystic fibrosis patients [1][2][4] - An independent Data Monitoring Committee (DMC) has reviewed the safety of the BX004 Phase 2b trial and recommended that the study continue with an adjusted dosing regimen, with topline results now expected in Q2 2026 [3][4] Company Updates - The company is collaborating with a third-party manufacturer to provide the FDA with the necessary information to resolve outstanding questions regarding the nebulizer device [2][4] - BiomX has previously reported positive results from Part 1 and Part 2 of the Phase 1b/2a trials, demonstrating safety, tolerability, and improvement in pulmonary function in a specific patient subgroup [5] Product Information - BX004 is a multi-phage cocktail targeting Pseudomonas aeruginosa, a significant cause of morbidity in cystic fibrosis patients [5] - The company plans to enroll approximately 60 patients in a randomized, double-blind, placebo-controlled Phase 2b trial, pending the resolution of the FDA clinical hold [5]