BiomX Inc. received positive feedback from the FDA for its clinical developmental pathway for BX011, a phage therapy targeting S. aureus in diabetic foot infections. The FDA supports BiomX’s plan to advance BX011 into DFI, following successful Phase 2 study of BX211 for DFO caused by S. aureus. The new formulation includes multiple proprietary phages, with support from $40 million in non-dilutive funding. FDA guidance allows for potential BLA submission without additional non-clinical studies, aligning with BiomX’s manufacturing and quality strategy. Plans are in place to initiate a Phase 2a clinical trial for DFI. BiomX aims to bring phage therapy into mainstream infectious disease care.

In March 2025, BiomX reported positive results from its Phase 2 trial targeting S. aureus in DFO, demonstrating significant reductions in ulcer size and depth. BiomX is a clinical-stage company developing natural and engineered phage therapies for chronic diseases with unmet needs. The BOLT platform is used to customize phage compositions against bacterial targets. BiomX operates under “safe harbor” provisions, making forward-looking statements about the potential benefits of BX011 and future development plans. Investors are advised to review risks and uncertainties in BiomX’s filings with the SEC.

Read more at GlobeNewswire: BiomX Announces Positive FDA Feedback Supporting