BiomX's Phage Therapy Shows Promise in Diabetic Foot Osteomyelitis

BiomX, an Israeli biotech company, has reported positive results from a phase 2 study of its phage therapy BX211 in patients with diabetic foot osteomyelitis (DFO). The trial, which enrolled 41 patients, demonstrated a reduction in ulcer size and depth compared to placebo, marking a significant milestone in the development of phage-based treatments for bacterial infections.

Promising Clinical Results

The phase 2 study evaluated BX211, a bacteriophage therapy targeting Staphylococcus aureus, in 26 patients who received the treatment and 15 who received placebo. Key findings include:

• A statistically significant reduction in ulcer size at Week 12 (p = 0.046), with a trend towards significance at Week 13 (p = 0.052)
• A significant decrease in ulcer depth at Week 13 (p = 0.048)
• Reduced expansion of ulcer area (p = 0.017)
• Favorable trends in additional clinical parameters, including evidence of DFO resolution on MRI or X-ray scans at Week 12

Jonathan Solomon, CEO of BiomX, stated, "This readout represents one of the strongest demonstrations to date of the therapeutic potential of phage therapy." He emphasized the importance of these results, noting that 30-40% of DFO cases currently lead to lower extremity amputations, accounting for the majority of the 160,000 lower limb amputations in diabetic patients annually in the U.S.

Strategic Acquisition Pays Off

The positive results from the BX211 trial validate BiomX's acquisition of Adaptive Phage Therapeutics last year. This strategic move has bolstered BiomX's pipeline with promising phage-based therapies, including BX211 for DFO and BX004 for chronic pulmonary infections in cystic fibrosis patients.

Future Plans and Financial Positioning

Following these encouraging results, BiomX is preparing for a phase 2/3 trial of BX211, pending feedback from the FDA. To support its ongoing research, the company recently secured $12 million through a series of financings. These funds will primarily finance a phase 2b study of BX004, a "phage cocktail" targeting Pseudomonas aeruginosa bacteria in cystic fibrosis patients.

Despite the positive news, BiomX's stock was trading down 8% premarket on Monday, highlighting the volatile nature of small-cap biotech investments.