NESS ZIONA, Israel — BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) is continuing its evaluation of the nebulizer device used for drug administration in the Company’s Phase 2b trial of BX004 in patients with cystic fibrosis. The Company is working with the third-party manufacturer to address recent FDA follow up information requests in order to lift the FDA’s clinical hold with respect to the trial. In parallel, an independent DMC has completed a safety review of the BX004 Phase 2b clinical trial.
BiomX recently received additional follow-up questions from the FDA related to the third-party nebulizer device used for BX004 administration. The Company is working closely with the device manufacturer to assemble the remaining additional information requested by the Agency. BiomX considers the outstanding items readily addressable to resolve the outstanding questions raised by the FDA while maintaining a productive and ongoing dialogue with the Agency. The Company expects enrollment in the U.S. to resume once this process is complete.
Separately, an independent DMC has conducted a safety review of the BX004 Phase 2b clinical trial. The review included participants who experienced adverse events, and following its evaluation, the DMC recommended that the study continue with an adjusted dosing regimen. In accordance with the recommendations, BiomX is updating the trial protocol, and pending availability of financial resources and other factors, topline results are now expected in the second quarter of 2026.
“We are encouraged by the DMC’s conclusion that the BX004 study may continue once the adjusted dosing regimen has been implemented. We remain committed to advancing a potential treatment for the unmet need of Pseudomonas aeruginosa (P. aeruginosa) infections in patients with cystic fibrosis,” said Jonathan Solomon, Chief Executive Officer of BiomX. “We are working closely with our device manufacturer to provide the FDA with the remaining clarifications and remain confident in the path forward for BX004. We look forward to reporting topline results in the second quarter of 2026.”
About BX004
BX004 is a fixed multi-phage cocktail designed to target P. aeruginosa, a major contributor to morbidity and mortality in people with cystic fibrosis. In February 2023, BiomX announced positive Part 1 Phase 1b/2a results demonstrating safety, tolerability, and microbiologic activity. In November 2023, BiomX announced positive topline results from Part 2, in which BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden versus placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<70%). Pending resolution of the FDA clinical hold on U.S. enrollment, and availability of funding resources, BiomX is expects to enroll up to approximately 60 patients in a randomized, double blind, placebo-controlled, multi-center Phase 2b trial evaluating lung function, bacterial load, and quality-of-life measures over an 8-week treatment period. BX004 has received Fast Track and Orphan Drug Designations from the U.S. FDA.
About BiomX
BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.
BiomX, Inc. Contact
Ben Cohen
Head Corporate Communications
[email protected]