BiomX Inc. announced positive topline safety and efficacy results on March 31, 2025, from its DFO Adaptive Novel Care Evaluation (DANCE™) Phase 2 trial evaluating BX211 for Diabetic Foot Osteomyelitis (DFO) associated with Staphylococcus aureus. The findings demonstrated BX211 to be safe and well-tolerated.
Patients receiving BX211 exhibited a statistically significant and sustained reduction of ulcer size (PAR), with a p-value of 0.046 at week 12 and 0.052 at week 13. A separation from placebo began at week 7, with a difference greater than 40% by week 10. BX211 also produced statistically significant improvements in ulcer depth at week 13 (p=0.048) and reduced the expansion of ulcer area (p=0.017).
Following these successful Phase 2 results, BiomX is planning for a Phase 2/3 trial, pending discussions and feedback from the U.S. Food and Drug Administration. DFO is a leading cause of amputation in diabetic patients, and these results suggest BX211 has the potential to address a significant unmet medical need.
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