BiomX announces publication on BX004 Phase 1b/2a Part 1 data

BiomX (PHGE) announced the publication of a peer-reviewed article in Nature Communications titled, “Phage therapy with nebulized cocktail BX004-A for chronic Pseudomonas aeruginosa infections in cystic fibrosis: a randomized first-in-human trial”. The article notably features previously unreported antimicrobial efficacy data from the Phase 1b/2a clinical trial and reinforces the strength of BiomX’s innovative approach to developing bacteriophage therapies for chronic disease with substantial unmet needs. The peer-reviewed results of Part 1 of BiomX’s BX004 Phase 1b/2a study include new analyses showing that BX004 achieved a substantially greater improvement of approximately 500-fold in bacterial reduction compared with placebo in CF patients. Notably, the data highlights that no bacterial resistance to BX004 emerged during the trial, addressing a critical limitation of traditional antibiotics. Findings from Part 1 of the Phase 1b/2a study were consistent with the results observed in Part 2.Part 1 of BiomX’s Phase 1b/2a study evaluated the safety, tolerability, pharmacokinetics, and anti-microbiologic activity of BX004 over a 7-day treatment period in nine CF patients with chronic P. aeruginosa pulmonary infection. The Part 1 data demonstrated: Strong Safety Profile: BX004 was safe and well-tolerated with no treatment-related safety events across all patients and dose levels tested. Successful bacterial reduction achieved: At day 15, BX004-treated patients showed a negative 1.42 log reduction in P. aeruginosa bacteria from baseline, while patients receiving placebo worsened by +1.26 log CFU/g. This 2.7 log CFU/g treatment effect was achieved on top of standard of care inhaled antibiotics. These findings resulted from an additional post hoc analysis and are being reported for the first time. Results at day 4 during BX004 treatment showed P. aeruginosa burden reduction.Therapeutic phages successfully reached and persisted at infection site: Phages were detected in all patients treated with BX004 during the dosing period, including in several patients up to day 15. As expected, no phages were detected in patients receiving placebo. No bacterial resistance to treatment: There was no emerging treatment-related resistance to BX004 during or after treatment with BX004, addressing efficacy of phage against bacteria where resistance is common amongst traditional antibiotics. Favorable shifts in microbiome composition post treatment: Microbiological signals included a reduction in P. aeruginosa relative abundance and an increase in microbiome alpha diversity in the phage-treated group, in contrast to the placebo group. The Nature Communications publication describes the full translational path from laboratory discovery to clinical testing. Environmental phages were isolated and screened using P. aeruginosa grown under conditions mimicking the CF lung environment. In silico screening confirmed the absence of known genes associated with antibiotic resistance or virulence.