BiomX Achieves Positive Phase 2 Results for BX211 in Treating Diabetic Foot Osteomyelitis

With support from the Naval Medical Research Center (NMRC) and the Medical Technology Enterprise Consortium (MTEC), BiomX is advancing phage therapy solutions for high-priority unmet medical needs in both civilian and military health settings.

BiomX Inc., a clinical-stage biotechnology company, has announced encouraging topline results from its Phase 2 trial evaluating BX211, a personalized bacteriophage therapy targeting Staphylococcus aureus in patients with Diabetic Foot Osteomyelitis (DFO). The trial demonstrated that BX211 was safe, well-tolerated, and led to statistically significant improvements in ulcer healing metrics compared to placebo.

Key Findings:

• Ulcer Size Reduction: Patients treated with BX211 exhibited a sustained and statistically significant reduction in ulcer size, with a percent area reduction (PAR) showing a p-value of 0.046 at week 12 and 0.052 at week 13. Notably, a separation from the placebo group was observed starting at week 7, with a difference exceeding 40% by week 10.
• Ulcer Depth Improvement: In patients whose ulcers had reached bone depth at baseline, BX211 treatment resulted in significant improvements in ulcer depth by week 13 (p=0.048).BioSpace+4Insider Monkey+4ATF+4
• Prevention of Ulcer Expansion: BX211 also significantly reduced the expansion of ulcer area compared to placebo (p=0.017).

These results underscore the potential of BX211 as a novel therapeutic option for DFO, a condition that currently leads to lower extremity amputations in 30-40% of cases, contributing to the approximately 160,000 amputations among diabetic patients annually in the United States.ATF+4Nasdaq+4BiomX, Inc.+4

BiomX plans to advance BX211 into a Phase 2/3 trial, pending discussions and feedback from the U.S. Food and Drug Administration (FDA).BioSpace+4Insider Monkey+4ATF+4

For more detailed information, please refer to the official press release: BiomX Announces Positive Topline Results from Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO).