Recent News 36 : BiomX Announces Successful Initiation of Phase 2b Trial with First Patient Dosed in BX004 Program in Patients with Cystic Fibrosis

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BiomX Announces Successful Initiation of Phase 2b Trial with First Patient Dosed in BX004 Program in Patients with Cystic Fibrosis

First patient dosing in Company’s Phase 2b trial marks pivotal milestone in phage therapy development program targeting antibiotic-resistant lung infections in Cystic Fibrosis patients; topline results are expected in Q1 2026

Prior Phase 1b/2a efficacy findings demonstrated complete bacterial clearance in 14.3% of patients after just 10 days of treatment

Feedback from U.S. Food and Drug Administration (FDA) anticipated in H2 2025, regarding plans to evaluate investigation and use of real-world evidence linking bacterial reduction to clinical outcomes; successful alignment could potentially streamline approval pathway for this urgently needed treatment option

NESS ZIONA, Israel, July 14, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the successful initiation of patient dosing in the Company’s Phase 2b trial with first patient dosed. The trial is evaluating BX004 for the treatment of cystic fibrosis (CF) patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) infections, which remain a leading cause of death in this patient population despite modern treatments. 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.

“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. “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. 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.”

The Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating BX004 in approximately 60 CF patients with chronic P. aeruginosa infections. Patients are randomized 2:1 to receive either BX004 or placebo via inhalation twice daily for 8 weeks. The trial is designed to measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function1, and enhanced quality of life as measured by CFQ-R2 and CRISS3. The trial builds on the successful Phase 1b/2a results, which showed BX004's potential ability to target and destroy P. aeruginosa that conventional treatments failed to eradicate.

About BX004

BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In February 2023, BiomX announced positive results from Part 1 of the Phase 1b/2a study, showing safety, tolerability, and microbiologic activity. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a trial, in which BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<70%). BiomX is now enrolling up to approximately 60 patients in a randomized, placebo-controlled Phase 2b trial of BX004 in CF patients with chronic P. aeruginosa lung infections. The 8-week study will assess lung function, bacterial load, and quality of life metrics. BX004 has received FDA Fast Track and Orphan Drug Designations.

Resources : 

https://ir.biomx.com/news-events/press-releases/detail/136/biomx-announces-successful-initiation-of-phase-2b-trial

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