BiomX Provides Update on BX004 Phase 2b Trial for the Treatment of Patients with Cystic Fibrosis

BiomX Inc. recently announced the US FDA has placed a clinical hold on the Phase 2b trial of BX004 for the treatment of patients with cystic fibrosis (CF).

In its notification, the FDA solely focused on the third-party nebulizer device utilized to deliver BX004. The BX004 drug product candidate has already been reviewed by the FDA and has been cleared for clinical investigational use with no concerns indicated to BiomX. Following the FDA’s hold notification, which the company believes to be temporary, BiomX promptly submitted the additional requested data which was generated independently by the well-established manufacturer of the nebulizer device, and this data is expected to provide the information required by the FDA to lift the hold. As a result of the FDA’s notification, patient screening and enrollment in the U.S. portion of the Phase 2b trial of BX004 have now been paused. In Europe, all components of the third-party nebulizer device are CE marked and thus have been deemed to meet applicable regulatory requirements. The study in the EU has been approved and enrollment and dosing of patients is continuing in accordance with the protocol.

“We are actively engaged with the FDA to promptly address their queries regarding the third-party nebulizer,” said Jonathan Solomon, Chief Executive Officer of BiomX. “Importantly, the FDA’s notification relates solely to the nebulizer, and we remain optimistic and confident that in response to the hold, we have provided the FDA with data that can satisfactorily support the use of the nebulizer and that this can be resolved promptly so that we may resume treating patients with cystic fibrosis in the US, BiomX remains committed to providing timely updates and full transparency to patients, physicians, and investors as the situation develops.”

BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa), a main contributor to morbidity and mortality in patients with CF. In February 2023, BiomX announced positive results from Part 1 of the Phase 1b/2a study, showing safety, tolerability, and microbiologic activity. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a trial, in which BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<70%). Pending resolution of the clinical hold imposed by the FDA, BiomX is expects to enroll up to approximately 60 patients in a randomized, double blind, placebo-controlled, multi-center Phase 2b trial of BX004 in CF patients with chronic P. aeruginosa lung infections. The 8-week study will assess lung function, bacterial load, and quality of life metrics. BX004 has received US FDA Fast Track and Orphan Drug Designations.

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, visit www.biomx.com.