BiomX announces results from Part 2 of the Phase 1b/2a trial of BX004

BiomX announced positive safety and efficacy results from Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis, or CF. “These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, CEO of BiomX. “In Part 2 of the study, BX004 showed clinically meaningful improvement in pulmonary function compared to placebo, as measured by relative FEV11 improvement and Cystic Fibrosis Questionnaire-Revised respiratory domain in a predefined subgroup of patients with reduced lung function2. Considering these results, the Company plans to advance the BX004 program to a larger, pivotal Phase 2b/3 trial, subject to regulatory feedback and availability of sufficient funding. In Part 2, 34 CF patients received nebulized study drug twice daily for 10 days and were randomized in a 2:1 ratio with 23 CF patients receiving BX004 and 11 patients receiving placebo. Endpoints included safety and tolerability, decrease in P. aeruginosa burden, sputum pharmacokinetics, FEV1, CFQ-R and CFRSD-CRISS. Highlights included: Study drug was safe and well-tolerated, with no related SAEs (serious adverse events) or related APEs to study drug; BX004 vs. placebo showed a positive clinical effect in a predefined subgroup of patients with reduced baseline lung function. Difference between groups at Day 17: relative FEV1 improvement of 5.67% and +8.87 points in CFQR respiratory symptom scale; In the BX004 arm, 3 out of 21 patients converted to sputum culture negative for P. aeruginosa after 10 days of treatment compared to 0 out of 10 in the placebo arm3.