NESS ZIONA, Israel — November 4, 2025 — Leads & Copy — BiomX Inc. (NYSE American: PHGE) has received positive feedback from the FDA on its clinical development plan for BX011, a phage therapy targeting Staphylococcus aureus in diabetic foot infections (DFI).
The FDA’s feedback supports BiomX’s plan to advance BX011 into DFI trials, following a Phase 2 study of BX211 for diabetic foot osteomyelitis (DFO). The decision to focus on DFI is based on a broader patient population, a large commercial opportunity, and clear regulatory guidelines.
BX011 includes proprietary phages previously evaluated in the BX211 study. The company’s phage therapies have been supported by approximately $40 million in funding from the U.S. DHA and Department of Navy. BiomX plans to initiate a Phase 2a clinical trial in DFI, pending financial resources and discussions with the U.S. Defense Health Agency (DHA).
The FDA provided guidance supporting a potential Biologics License Application (BLA), expecting no additional non-clinical studies. Comments on CMC align with BiomX’s manufacturing and quality strategy, confirming BX011’s development plan is in accordance with FDA guidance for DFI products.
Jonathan Solomon, CEO of BiomX, said the FDA’s comments reinforce the goal of bringing phage therapy into mainstream infectious disease care. In March 2025, BiomX reported positive results from its Phase 2 BX211 trial, which showed significant ulcer reduction with separation from placebo at week 7 and ulcer depth improvements at week 13.
Ben Cohen
Head Corporate Communications
benc@biomx.com
Source: BiomX
