Based on results from Part 2 of the Phase 1b/2a trial, BiomX said that it plans to advance its BX004 nebulized phage cocktail for the treatment of chronic P. aeruginosa lung infections in cystic fibrosis patients into a Phase 2b/3 trial “subject to regulatory feedback and availability of sufficient funding.” The study data demonstrated limited efficacy, with culture conversion following 10 days of treatment occurring in 3 out of 21 CF patients who received BX004 compared to zero out of 10 patients who received placebo.
In February 2023, the company announced results from the first part of the study, which enrolled 9 patients, saying that those data demonstrated “preliminary evidence of efficacy.” BiomX says that in the second part of the study the reduction in P. aeruginosa burden “in a prespecified subgroup of patients on standard of care inhaled antibiotics on continuous regimen” was greater than the reduction demonstrated in the first part of the study.
In addition, BiomX CEO Jonathan Solomon said, “These study results are highly encouraging especially given the short treatment duration of 10 days with BX004. In Part 2 of the study, BX004 showed clinically meaningful improvement in pulmonary function compared to placebo, as measured by relative FEV1 improvement (5.67% at Day 17, 1 week after end of treatment) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain (8.87 points at Day 17) in a predefined subgroup of patients with reduced lung function.”
According to BiomX, BX004 was well tolerated, with no serious adverse effects, no acute pulmonary exacerbations, and no evidence of phage resistance during the study.
Read the BiomX press release.
