Oct 17, 2025 (PRISM News via COMTEX) --
BiomX Inc. (NYSE: PHGE), a clinical-stage company developing natural and engineered bacteriophage therapies, announced progress in addressing regulatory feedback on its BX004 program for cystic fibrosis (CF), while also receiving new written guidance from the U.S. Food and Drug Administration (FDA) that may open additional avenues for late-stage development.
The FDA had previously placed a clinical hold on the U.S. arm of the company's Phase 2b trial, citing questions related to the third-party nebulizer used to deliver BX004. BiomX stated that it has now fully addressed the FDA's queries, which it described as "narrow in scope" and limited to technical performance aspects of the device, not the drug itself. The company also submitted responses to a subsequent request for limited clarifications, expressing confidence that it has satisfied the agency's concerns.
Meanwhile, European enrollment and dosing have continued ahead of schedule, with the Phase 2b trial on track to deliver topline results in the first quarter of 2026. All nebulizer components used in Europe are CE-marked and approved for use in the EU.
"We've made meaningful progress in both addressing the FDA's feedback and advancing patient enrollment in Europe," said Jonathan Solomon, CEO of BiomX. "We believe the information provided fully resolves the technical questions related to the nebulizer and look forward to a potential lifting of the U.S. clinical hold soon."
In parallel, BiomX reported receiving new FDA guidance recognizing the unmet need for treatments targeting chronic Pseudomonas aeruginosa infections in CF patients, even with the availability of CFTR modulators. The agency also outlined potential strategies for Phase 3 trial design, including ways to refine inclusion criteria and enrich patient populations to enhance the ability to demonstrate clinical benefit.
"We are encouraged by the FDA's recognition of the ongoing need for new therapies in this space and its constructive input on future study design," Solomon added. "This feedback supports our belief that BX004 could play a meaningful role in addressing chronic bacterial infections in cystic fibrosis."
BiomX plans to incorporate the FDA's recommendations into future development plans and anticipates an End-of-Phase 2 meeting with the agency following completion and analysis of the Phase 2b results.
If successful, BX004 could represent one of the first bacteriophage-based therapeutics to advance into late-stage clinical development for CF-related infections--a major step forward in precision antibacterial therapy.
The post BiomX Announces FDA Feedback Supporting Expanded Development Pathways for BX004 in Cystic Fibrosis appeared first on PRISM MarketView.
COMTEX_469587244/2927/2025-10-17T10:00:53
