BiomX (NYSE: PHGE) has announced the initiation of patient dosing in its Phase 2b trial evaluating BX004 for the treatment of cystic fibrosis (CF) patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) infections—a leading cause of death in this patient population despite modern treatments.
According to BiomX, pending topline results expected in the first quarter of 2026, BX004 could potentially be positioned as the leading phage-based therapy for CF patients with these deadly infections.
In a statement, Jonathan Solomon, CEO of BiomX, commented, “This first patient dosing marks a significant milestone for our BX004 program and for CF patients with chronic P. aeruginosa infections who desperately need new options. We’re seeing tremendous enthusiasm from both patients and investigators based on our encouraging Phase 1b/2a results, in which 14.3% of patients cleared infections completely after 10 days of treatment. Notably, this included individuals who had been living with chronic infections for over a decade, making these outcomes particularly meaningful and rarely seen in this population.”
He added, “In the second half of 2025, we anticipate feedback from the FDA regarding our plans on the analyses of real-world evidence to link bacterial reduction to clinical outcomes. Regulatory alignment on a microbiological endpoint would streamline the approval pathway and provide a means of addressing these patients with urgent unmet needs. With both Fast Track and Orphan Drug designations already secured, we believe we are well-positioned to further develop our phage-based therapy for these life-threatening infections, pending a positive topline trial readout, which is expected in the first quarter of 2026.”
