BiomX announced that it has initiated a Phase 2b study of its BX004 inhaled phage cocktail cystic fibrosis patients with chronic P. aeruginosa lung infections. BiomX had said in November 2023 that it planned to advance BX004 into a Phase 2b/3 trial based on data from a Phase 1b/2a trial that it had recently completed. In February 2025, the company announced that it had raised approximately $12 million from the Cystic Fibrosis Foundation and other investors to fund the Phase 2b trial.
The Phase 2b trial is expected to enroll approximately 60 CF patients who have chronic P. aeruginosa infections. The patients will get either nebulized BX004 or nebulized placebo twice a day over 8 weeks, with the primary endpoint being change in the burden of P. aeruginosa in the sputum at 8 weeks after the initiation of dosing.
BiomX CEO Jonathan Solomon 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.”
Solomon continued, “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 positive topline trial readout, which readout is expected in the first quarter of 2026.”
Read the BiomX press release
