Israeli biotech BiomX has announced data from the first part of a Phase 1b/2a trial of the company’s BX004 nebulized phage cocktail for the treatment of P. aeruginosa lung infections in cystic fibrosis patients demonstrating a reduction in P. aeruginosa burden. The first portion of the study, which is supported by the Cystic Fibrosis Foundation, enrolled 9 CF patients who received either BX004 or placebo over 7 days. The company said that the second part of the study is expected to enroll 24 CF patients and will compare the safety and efficacy of BX004 to placebo, with results expected in the third quarter of 2023.
BiomX CEO Jonathan Solomon said, “We are very excited to share these positive results from Part 1 of our Phase 1b/2a CF study. Although Part 1 of the study was designed primarily to assess safety and tolerability of BX004, a goal that was achieved, we are highly encouraged to see 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. The BiomX Phase 1b/2a clinical trial is the first reported double blind placebo-controlled study evaluating a cocktail-based phage product to demonstrate notable reductions in bacterial burden in cystic fibrosis. Based on the favorable safety profile in Part 1, as confirmed by the Data Monitoring Committee, we have already dosed patients in Part 2 of the Phase 1b/2a study and expect to report results in the third quarter of 2023.”
In addition to the study results, BiomX announced that it has raised $7.5 million in a private placement to support clinical development of BX004. The company said that investors included the CF Foundation and another previous investor, OrbiMed.
Read the BiomX press release on the Phase 1b/2a trial.
Read the BiomX press release on the private placement.
