BiomX’s phage therapy shows promise in Phase II diabetic foot infections study

BiomX has announced positive topline results from its Phase 2 trial evaluating BX211, a phage therapy for the treatment of diabetic foot osteomyelitis (DFO) associated with Staphylococcus aureus1 6.

Key findings from the trial include:

BX211 was found to be safe and well-tolerated1 6.
Statistically significant and sustained reduction in ulcer size (PAR) was observed (p = 0.046 at week 12)1 6.
Separation from placebo started at week 7, with a difference greater than 40% by week 101 3.
Significant improvements in ulcer depth at week 13 (p=0.048) and reduced expansion of ulcer area (p=0.017)1 6.

The study enrolled 41 patients randomized at a 2:
1 ratio, with 26 receiving BX211 and 15 receiving placebo1. Treatment involved intravenous and topical administration of BX211 at Week 1, followed by weekly topical doses through Week 133.

BiomX CEO Jonathan Solomon stated that these results represent "one of the strongest demonstrations to date of the therapeutic potential of phage therapy"6. The company is now planning for a Phase 2/3 trial, pending discussions with the FDA1 6.

This advancement in phage therapy could potentially address a significant unmet need in DFO treatment, as 30-40% of cases currently lead to lower extremity amputations6. The success of BX211 in this trial also highlights the broader potential of phage therapy in combating antibiotic-resistant infections7.