BiomX Inc. announced on July 14, 2025, the successful initiation of patient dosing in its Phase 2b trial for BX004. This trial is evaluating BX004 for the treatment of cystic fibrosis (CF) patients with chronic pulmonary infections caused by Pseudomonas aeruginosa, a leading cause of death in this patient population.
The Phase 2b trial is a randomized, double-blind, placebo-controlled study designed to enroll approximately 60 CF patients. Patients will receive either BX004 or placebo via inhalation twice daily for 8 weeks, with topline results anticipated in the first quarter of 2026.
This milestone follows encouraging Phase 1b/2a results, where 14.3% of patients achieved complete bacterial clearance after 10 days of treatment. BiomX also anticipates feedback from the U.S. Food and Drug Administration (FDA) in the second half of 2025 regarding plans to evaluate real-world evidence, which could potentially streamline the approval pathway.
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