BiomX Presents Preclinical Results of its Phage Therapy Program Targeting Primary Sclerosing Cholangitis

BiomX Inc. (NYSE: PHGE), a clinical-stage company developing both natural and engineered phage therapies, today presents new data from the company's Primary Sclerosing Cholangitis (PSC) program at the American Association for the Study of Liver Disease (AASLD) Conference in Boston.

In the study, BiomX researchers identified and characterized phages targeting pathogenic bacterial strains that are hypothesized as disease modifying in PSC, a rare progressive liver disorder with no FDA-approved treatment, affecting approximately 30,000 patients in the US. The target bacterial strains of Klebsiella pneumoniae (Kp) were isolated from the stool of patients with PSC and were previously shown to induce a Th17 inflammatory response in the liver and to disrupt the intestinal epithelial barrier in mice¹. Gut permeability ("leaky gut") may lead to microbial infection of bile, resulting in inflammation and fibrosis within the liver of PSC patients, suggesting that Kp may serve as a therapeutic target for phage therapy.

In the study presented today, cohort analyses based on metagenomic sequencing of stool samples collected from over 350 PSC patients and healthy controls from three countries, revealed that the prevalence and abundance of the target bacteria is higher in PSC patients compared to healthy controls, and that abundance is associated with disease severity (positively correlated with advanced liver fibrosis) and longer disease duration. BiomX researchers further conducted phage hunting efforts resulting in over 20 phages, from which over a 100 combinations (cocktails) were designed and compared for their ability to effectively eradicate Kp in vitro. This process allowed for the selection of a phage cocktail that was able to substantially reduce bacterial burden of the target Kp strains in vivo by over 3 orders of magnitude, while also efficiently limiting the emergence of mutant bacteria with resistance to the cocktail.

"We believe that phage therapy holds promise for the treatment of patients with PSC, who are in dire need of novel therapeutic approaches to this disease for which there are presently no satisfactory treatments." said Jonathan Solomon, BiomX's CEO. "We are encouraged by these results and are committed to continue moving this program forward to clinical trials, planned for the first half of 2021."

PSC is characterized by inflammation and fibrosis within the bile ducts. Scarring of the liver, or cirrhosis, eventually develops and many patients ultimately require a liver transplant. Recent studies suggest linkage between the microbiome and PSC, especially given that compromises in the intestinal barrier caused by alterations in the microbiome may expose the bile ducts and liver to altered levels of bacteria and their products, which may trigger aberrant inflammatory responses.

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About BiomX
BiomX is a clinical-stage company developing both natural and engineered phage cocktails designed to target and destroy bacteria that affect the appearance of skin, as well as harmful bacteria in chronic diseases, such as IBD, PSC, and cancer. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.
www.biomx.com

¹ Nakamoto et al. Nature Microbiology, 2019