Investigational Phage Therapy Shows Positive Topline Results for Diabetic Foot Osteomyelitis
Yesterday, an Israeli-based company, BiomX, announced results from its phase 2 trial studying its investigational phage therapy, BX211, which was found to be safe, well-tolerated, and demonstrated a clinical benefit for the treatment of diabetic foot osteomyelitis (DFO) associated with Staphylococcus aureus.
Specifically, BX211 produced a sustained and statistically significant percent area reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10.
“The promising topline data in this trial provide an important inflexion point for this approach and its potential to address the most challenging infections,” Robert T. “Chip” Schooley, MD, distinguished professor of Medicine, Division of Infectious Diseases and Global Public Health and co-director, Center for Innovative Phage Applications and Therapeutics at the University of California, San Diego, said in a statement.
The BiomX trial is a randomized, double-blind, placebo-controlled, multi-centre study investigating the safety, tolerability, and efficacy of BX211 for individuals with DFO associated with S aureus. The study enrolled a total of 41 patients randomized for treatment at a 2:1 ratio, 26 of whom received intravenous (IV) and topical administration of BX211 on week 1 followed by a topical weekly dose through week 12, while 15 patients were assigned to the placebo arm. Over the 12-week treatment period, all subjects (treatment and placebo) were also treated by the standard of care, including with systemic antibiotic therapy as appropriate.
A readout of study results at week 13 evaluated the healing of the wound associated with osteomyelitis. The primary efficacy endpoint was PAR of the study ulcer through week 13. The study design was partly guided by experience with numerous compassionate cases using phage therapy to treat DFO and osteomyelitis.
“Today, 30-40% of DFO cases lead to lower extremity amputations related to serious bacterial infections, accounting for the majority of the 160,000 lower limb amputations in diabetic patients each year in the United States,” BiomXCEO Jonathan Solomon, said in a statement.
References
1. BiomX Announces Positive Topline Results from Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO). BiomX press release. March 31, 2025. Accessed April 1, 2025.
https://ir.biomx.com/news-events/press-releases/detail/130/biomx-announces-positive-topline-results-from-phase-2-trial
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