BiomX Inc. (AMEX:PHGE) saw its stock jump 60% after announcing the commencement of patient dosing in its Phase 2b clinical trial evaluating BX004 for cystic fibrosis patients suffering from chronic Pseudomonas aeruginosa infections.
This randomized, double-blind, placebo-controlled study will enroll around 60 cystic fibrosis patients, who will receive either BX004 or a placebo via inhalation twice daily over an 8-week period. The company expects to report topline data in Q1 2026.
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.”
The trial builds on promising Phase 1b/2a results, where 14.3% of patients fully cleared infections after just 10 days of treatment, including those with infections lasting over a decade.
BiomX’s targeted phage therapy focuses on pathogenic bacteria that remain a leading cause of mortality in cystic fibrosis patients despite advances in treatment. BX004 has already received Fast Track and Orphan Drug designations from the FDA.
The Phase 2b study will assess several efficacy endpoints, such as bacterial load reduction, lung function improvement, and quality of life enhancements. BiomX anticipates receiving FDA feedback in the latter half of 2025 on connecting bacterial reduction to clinical outcomes.
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