BioMx Inc. has announced the completion of patient enrollment for its Phase 2 clinical trial of BX201, a phage-based therapeutic, targeting Diabetic Foot Osteomyelitis (DFO) associated with Staphylococcus aureus. The company anticipates releasing topline results from the trial in the first quarter of 2025.
BX201 for Diabetic Foot Osteomyelitis
The Phase 2 trial is a randomized, double-blind, placebo-controlled, multi-center study designed to assess the safety, tolerability, and efficacy of BX201 in conjunction with standard-of-care antibiotics in patients with DFO caused by S. aureus. Participants are randomized in a 2:1 ratio to receive either BX201 or a placebo. The treatment involves weekly topical and intravenous administration in the first week, followed by topical application only for the subsequent 11 weeks. All subjects continue to receive standard antibiotic treatment as deemed necessary.
Jonathan Solomon, CEO of BioMx Inc, highlighted the significance of BX201, stating it has "the potential to dramatically transform treatment for patients suffering from DFO associated with Staphylococcus A." He noted the high unmet need, citing approximately 160,000 lower limb amputations annually in diabetic patients in the US, with 85% estimated to be caused by DFO.
The current standard of care, antibiotic therapy, fails in 30-40% of cases due to antibiotic resistance, biofilm accumulation, and poor blood supply, which limits antibiotic concentration at the infection site. Compassionate use reports in scientific literature have shown positive outcomes in 11 of 12 DFO cases treated with phage therapy, including wound healing and amputation avoidance.
BX004 for Cystic Fibrosis
BioMx is also developing BX004, a novel phage cocktail, for treating chronic lung infections in cystic fibrosis (CF) patients caused by Pseudomonas aeruginosa. The company is continuing preparations for the Phase 2b study. However, manufacturing delays have pushed the expected topline results to the first half of 2026.
Despite the delay, BioMx presented positive safety and efficacy results from the BX004 Phase 1b/2a trial at the North American Cystic Fibrosis Conference and the European Respiratory Society's annual meeting. Key findings included that 14.3% of patients (3 out of 21) in the BX004 arm converted to sputum culture negative for P. aeruginosa after 10 days of treatment, compared to 0% in the placebo arm. Additionally, lung function, measured by FEV1, increased in subjects receiving the cocktail compared to placebo in a subgroup on continuous inhaled antibiotics with lower lung function (FEV1 lower than 70%).
Financial Update
Marina Wolfson, CFO of BioMx Inc, reported that the company’s cash, short-term deposits, and restricted cash totaled $24.7 million as of September 30, 2024. The company estimates that these funds will be sufficient to finance operations into the fourth quarter of 2025.
Research and development expenses for the third quarter of 2024 were $7.3 million, compared to $5.6 million for the same period in 2023. This increase is primarily due to preparations for the Phase 2b trial of BX004, increased expenses related to the BX201 clinical trial, and higher rent and related expenses. These increases were partially offset by higher grants received following the acquisition of Adaptive Phage Therapeutics (APT).
