BiomX Initiates Phase 2b Trial for BX004, a Phage Therapy Targeting Antibiotic-Resistant Lung Infections in Cystic Fibrosis Patients.

BiomX Inc. has initiated a Phase 2b trial for BX004, a phage therapy to treat antibiotic-resistant lung infections in cystic fibrosis patients. The trial aims to evaluate efficacy endpoints and expects topline results in Q1 2026. Previous Phase 1b/2a trial results showed 14.3% complete bacterial clearance after 10 days. The FDA has granted Fast Track and Orphan Drug designations for BX004. BiomX anticipates feedback from the FDA regarding the use of real-world evidence to support clinical outcomes, which could streamline the approval pathway.