BiomX Inc. (PHGE), a clinical-stage company focused on phage therapies that target specific pathogenic bacteria, announced Monday positive, topline safety and efficacy results from its Phase 2 trial evaluating BX211 for diabetic foot osteomyelitis or DFO.
Following the successful Phase 2 readout of BX211, the company said it is planning for a Phase 2/3 trial, pending discussions and feedback from the U.S Food and Drug Administration.
In pre-market activity on the NYSE, BiomX shares were losing around 7 percent.
DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. BX211 is a phage treatment for the treatment of DFO associated withS. aureus.
BiomX's Phase 2 trial is a randomized, double-blind, placebo-controlled, multi-center study investigating the safety, tolerability, and efficacy of BX211 for individuals with DFO associated with S. aureus.
The findings from the DFO Adaptive Novel Care Evaluation (DANCE) Phase 2 trial evaluating its BX211 phage treatment for DFO associated with Staphylococcus aureus (S. aureus) demonstrated BX211 to be safe and well-tolerated.
In the trial, patients receiving BX211 exhibited statistically significant and sustained reduction of ulcer size, with a separation from placebo starting at week 7 and a difference greater than 40% by week 10.
In addition, BX211 also produced statistically significant improvements in both ulcer depth at week 13, and in reducing the expansion of ulcer area. Over the 12-week treatment period, all patients were treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate.
Jonathan Solomon, BiomX's Chief Executive Officer, said, "We believe these data represent one of the strongest demonstrations to date of the therapeutic potential of phage therapy. .. Based on the results announced today, we believe BiomX's novel phage therapy approach has the potential to help address the major unmet need in DFO. Moreover, in an era of modern conflict and rising antibiotic-resistant wounds, the need for innovative wound care solutions underscores the broader relevance of this program beyond DFO."
BiomX expects to present additional data from the Phase 2 study at upcoming scientific conferences.
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