BiomX stock soars after initiating Phase 2b trial for cystic fibrosis therapy
Investing.com -- BiomX (NYSE:PHGE) Inc. (NYSE American:PHGE) stock surged 60% after the clinical-stage company announced it has successfully initiated patient dosing in its Phase 2b trial evaluating BX004 for cystic fibrosis patients with chronic Pseudomonas aeruginosa infections.
The randomized, double-blind, placebo-controlled study will evaluate approximately 60 cystic fibrosis patients, with participants receiving either BX004 or placebo via inhalation twice daily for 8 weeks. The company expects topline results in the first quarter of 2026.
"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," said Jonathan Solomon, Chief Executive Officer of BiomX.
The trial follows encouraging Phase 1b/2a results where 14.3% of patients completely cleared infections after 10 days of treatment, including individuals who had been living with chronic infections for over a decade.
BiomX’s phage therapy targets specific pathogenic bacteria that remain a leading cause of death in cystic fibrosis patients despite modern treatments. The company has already secured Fast Track and Orphan Drug designations from the FDA for BX004.
The Phase 2b trial will measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function, and enhanced quality of life. BiomX anticipates feedback from the FDA in the second half of 2025 regarding plans to link bacterial reduction to clinical outcomes.
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