BiomX’s acquisition of Adaptive Phage Therapeutics is looking like a good bet now that one of the treatments from the deal has been shown to reduce ulcers in a phase 2 study of patients with a diabetic foot infection.
The relatively small trial enrolled 41 patients with diabetic foot osteomyelitis (DFO), a painful bone infection, which was associated with the bacteria Staphylococcus aureus. Twenty-six of these individuals received intravenous and topical administration of BiomX’s phage therapy BX211 at Week 1, followed by a topical weekly dose through to Week 12, while 15 patients received placebo.
The trial looked specifically at ulcer size, depth and expansion as well as how well treatment could reduce all three. When it came to Percent Area Reduction (PAR) of ulcer size, this by a razor-thin margin hit statistical significance at Week 12 (p = 0.046), while just missing at Week 13 (p = 0.052). BiomX said in its release that there was a "separation from placebo starting at" Week 7 that saw a "difference greater than 40%" by Week 10.
Meanwhile, when again compared to placebo, BX211 saw another paper-thin win in ulcer depth at Week 13 (p = 0.048) but hit more comfortably statistical significance when it came to reducing the expansion of ulcer area (p = 0.017).
In addition, there was a “favorable trend compared to placebo across several additional clinical parameters,” such as evidence of patients’ DFO resolving when checked by an MRI or X-ray scan at Week 12.
Phage therapy involves the use of viruses that target specific bacteria to treat infections. BiomX picked up BX211 as part of its acquisition of U.S.-based Adaptive Phage a year ago.
BiomX’s CEO Jonathan Solomon said this morning’s readout “represents one of the strongest demonstrations to date of the therapeutic potential of phage therapy.”
“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 U.S.,” Solomon added.
BiomX is now gearing up for a phase 2/3 trial of BX211 while it waits for feedback from the FDA.
Last month, the Israeli biotech brought in $12 million via a series of financings in order to finance a phase 2b study of BX004, a so-called “phage cocktail” also acquired from the merger with Adaptive Phage. Here, BiomX is targeting at chronic pulmonary infections caused by Pseudomonas aeruginosa bacteria in cystic fibrosis patients.
The nano-cap biotech was trading down 8% premarketing Monday morning.