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

Core Insights - The initiation of patient dosing in BiomX's Phase 2b trial for BX004 represents a significant milestone in the development of phage therapy targeting antibiotic-resistant lung infections in cystic fibrosis (CF) patients [1][2] - Topline results from the trial are expected in Q1 2026, with the potential for BX004 to become a leading phage-based therapy for CF patients suffering from chronic Pseudomonas aeruginosa infections [1][2] Company Overview - BiomX Inc. is a clinical-stage company focused on developing natural and engineered phage therapies aimed at specific pathogenic bacteria, particularly for chronic diseases with substantial unmet needs [4] - The company has received FDA Fast Track and Orphan Drug designations for BX004, which is a fixed multi-phage cocktail designed to treat chronic pulmonary infections caused by P. aeruginosa in CF patients [3][4] Clinical Trial Details - The Phase 2b trial is a randomized, double-blind, placebo-controlled study involving approximately 60 CF patients, with a 2:1 randomization to receive either BX004 or placebo via inhalation twice daily for 8 weeks [2][3] - The trial aims to measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function, and enhanced quality of life metrics [2][3] Previous Findings - Prior Phase 1b/2a trials demonstrated that 14.3% of patients achieved complete bacterial clearance after just 10 days of treatment, including patients with chronic infections lasting over a decade [1][2] - Positive topline results from Part 2 of the Phase 1b/2a trial indicated improvements in pulmonary function associated with reduced P. aeruginosa burden compared to placebo in a predefined subgroup of patients [3]