BiomX's phage therapy succeeds in Phase 2 diabetic bone infection trial

BiomX, an Israeli biotechnology firm, has achieved promising results with its antibacterial virus candidate, BX211, in a mid-stage clinical trial aimed at treating diabetic foot osteomyelitis (DFO) linked to S. aureus infections. This innovative approach, utilizing bacteriophage therapy, could potentially address challenges posed by antibiotic resistance, offering a promising alternative for patient care.

BX211 demonstrated substantial effectiveness in reducing the size of foot ulcers, a common complication of diabetic bone infections. According to BiomX's recent announcement, the treatment achieved a "statistically significant and sustained" reduction in ulcer size compared to placebo as early as seven weeks into the trial. By the tenth week, the difference in the primary endpoint between the BX211 group and the placebo group exceeded 40 percentage points. This result underscores the potential of BX211 in effectively managing DFO, a condition that often results in limited treatment options.

The Phase 2 DANCE trial involved 41 patients suffering from DFO associated with S. aureus infections. Among these participants, 26 received BX211, starting with both intravenous and topical doses during the initial week, followed by weekly topical treatments for a total of 13 weeks. The results were promising not just in terms of ulcer size reduction, but also in improving ulcer depth, offering a significant advancement in wound management. BiomX reported that BX211 was both safe and well-tolerated among participants, further solidifying its potential as a therapeutic candidate.

Phage therapy, the cornerstone of BX211's mechanism, employs bacteriophages—viruses that specifically target and destroy bacteria. These phages infect pathogenic bacteria, replicating within them until the bacterial cells rupture and die. This approach is being explored as a solution for infections that are resistant to conventional antibiotics or where standard treatments are insufficient. Given the prevalence of antibiotic-resistant strains, BiomX's strategy could play a crucial role in enhancing treatment outcomes for various bacterial infections.

Diabetic foot osteomyelitis is particularly challenging, as traditional treatment methods often prove inadequate. In approximately 30% to 40% of cases, patients face possible amputation of the affected foot, a drastic measure that still leaves them with a high mortality rate—about 50% within five years post-amputation. BX211 aims to address this critical gap in care by offering a more targeted and effective treatment option.

BX211 is composed of bacteriophages specifically targeting S. aureus, which are selected from BiomX's extensive phage bank. Each patient's infection profile is matched with suitable phages using a proprietary phage susceptibility test, ensuring a personalized and precise therapeutic approach.

In addition to BX211's development, BiomX is advancing BX004, another phage therapy candidate aimed at treating chronic pulmonary infections in cystic fibrosis patients. BX004 is also undergoing mid-stage clinical trials, further highlighting BiomX's commitment to leveraging phage therapy across multiple bacterial infections.

In March 2024, BiomX expanded its capabilities by merging with Adaptive Phage, a strategic move that enhanced its resources and expertise in phage therapy development. The merger was accompanied by securing $50 million in funding, aimed at propelling its phage therapy candidates through clinical evaluations.

BiomX plans to present more comprehensive data from the Phase 2 study at an upcoming scientific conference, with ambitions for a Phase 2/3 trial, pending feedback from the FDA. As BiomX continues its innovative work in phage therapy, it holds the potential to revolutionize the treatment landscape for antibiotic-resistant infections, offering new hope to patients with limited options.