BiomX(US:PHGE) Newsfilterยท2025-03-31 10:30Core Viewpoint - BiomX Inc. announced positive topline safety and efficacy results from its Phase 2 trial of BX211, a phage therapy for diabetic foot osteomyelitis (DFO) associated with Staphylococcus aureus, indicating significant potential in addressing unmet medical needs in this area [1][2][3]. Summary of Phase 2 BX211 Results - The Phase 2 trial was a randomized, double-blind, placebo-controlled study involving 41 patients, with a treatment ratio of 2:1, where 26 received BX211 and 15 received placebo [4]. - BX211 was found to be safe and well-tolerated, showing a statistically significant reduction in ulcer size (Percent Area Reduction, PAR) with p-values of 0.046 at week 12 and 0.052 at week 13, with a notable separation from placebo starting at week 7 and a difference greater than 40% by week 10 [3][12]. - Statistically significant improvements were also observed in ulcer depth at week 13 (p=0.048) and in reducing the expansion of ulcer area (p=0.017) compared to placebo [12]. - The study demonstrated favorable trends across additional clinical parameters, including evidence of resolving DFO by MRI/X-ray and improvement in the Wagner scale [12]. Future Plans - Following the successful Phase 2 results, BiomX plans to initiate a Phase 2/3 trial of BX211, pending feedback from the U.S. Food and Drug Administration (FDA) [1][9]. - The company will present additional data from the Phase 2 study at upcoming scientific conferences [5]. Industry Context - The results highlight the therapeutic potential of phage therapy, particularly in treating infections where antibiotic resistance is a concern, addressing a significant unmet need in DFO, which currently leads to a high rate of lower extremity amputations [2][12]. - The company emphasizes the broader relevance of phage therapy in modern conflict scenarios and rising antibiotic-resistant infections, indicating a shift in treatment paradigms for chronic infections [2].