BiomX has announced positive results from part 1 of a phase 1b/2a study evaluating BX004, a phage cocktail, for treating chronic pulmonary infections caused by P. aeruginosa in patients with cystic fibrosis.

The first part of the study assessed the safety and tolerability of BX004 over a seven-day treatment period in nine cystic fibrosis patients (seven on BX004, two on placebo) with chronic P. aeruginosa pulmonary infection in a single ascending dose and multiple dose design.

The study found no safety events related to treatment with BX004. 

Additionally, the study showed preliminary evidence of efficacy in patients treated with BX004 despite the small sample size and short duration of treatment. At day 15, mean P. aeruginosa burden was reduced by 1.42 log10 CFU/g compared to 0.28 log10 CFU/g in those receiving placebo. 

“We would like to thank all of the patients, physicians, and healthcare providers who participated in part 1 of the study and our dedicated team and collaborators for all their work. We also appreciate the continued support from the Cystic Fibrosis Foundation, which, through its Therapeutics Development Award program, provides significant resources to help advance new therapeutics for CF,” says Jonathan Solomon, CEO of BiomX, in a press release.

Based on the favorable safety profile in part 1, as confirmed by the Data Monitoring Committee, BiomX has already dosed patients in part 2 of the Phase 1b/2a study and expects to report results in the third quarter of 2023.

“Despite the available new CFTR-directed therapies, CF patients continue to suffer from intractable, persistent infections, such as those caused by P. aeruginosa, and new treatment approaches are clearly needed,” says Eitan Kerem, MD, professor of pediatrics and former chairman of the department of pediatrics and the pediatric pulmonology unit of the Hadassah University Medical Center in Jerusalem, in a press release. “BiomX’s study results, in addition to previous data gathered through compassionate use, strongly endorse the potential of phage-based treatments in effectively targeting pathogenic bacteria within infected tissue.”