BiomX Inc. initiated patient dosing in its Phase 2b trial for BX004, a phage therapy targeting antibiotic-resistant •Pseudomonas aeruginosa• lung infections in cystic fibrosis (CF) patients. Prior Phase 1b/2a trials showed promising results, with 14.3% of patients achieving complete bacterial clearance after just 10 days. Topline results from the current trial are anticipated in Q1 2026, and the company expects feedback from the FDA in H2 2025 regarding the use of real-world evidence to potentially streamline the approval process.
This development holds significant promise for CF patients battling chronic •P. aeruginosa• infections, a leading cause of death in this population. Current treatments often struggle to eradicate these infections, leaving a critical need for new therapeutic options. BX004’s potential to clear these persistent infections offers a beacon of hope for improved lung function, quality of life, and ultimately, survival. The potential to streamline the approval pathway based on real-world evidence could accelerate access to this much-needed therapy.
The Phase 2b trial is a randomized, double-blind, placebo-controlled study involving roughly 60 CF patients with chronic •P. aeruginosa• infections. Participants will receive either BX004 or a placebo via inhalation twice daily for eight weeks. Efficacy will be evaluated based on bacterial reduction, lung function improvement, and quality of life measures. BX004 has already received Fast Track and Orphan Drug designations from the FDA.
Positive Phase 2b results could establish BX004 as a leading phage-based therapy for these life-threatening infections. This could represent a paradigm shift in CF treatment, offering a new approach to combatting antibiotic resistance and improving patient outcomes. Successful alignment with the FDA on utilizing real-world evidence could expedite BX004’s availability to patients and potentially pave the way for broader applications of phage therapy in other infectious diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
