Therapy Areas: Autoimmune
Journal Cell Publsihes Research Demonstrating Proof-of-Concept Assessment of Orally Administered Phage Treatment in Preclinical Model of Inflammatory Bowel Disease
4 August 2022 - - The journal, Cell has published a scientific paper titled "Targeted suppression of human IBD-associated gut microbiota commensals by phage consortia for treatment of intestinal inflammation", Israeli clinical-stage microbiome company BiomX Inc. (NYSE American: PHGE) said.

The research was conducted across several organizations, including scientists from BiomX and the Weizmann Institute of Science (Rehovot, Israel).

This research is based on prior work by Prof. Honda et al. from Keio University (Tokyo, Japan) identifying strains of Klebsiella pneumoniae as potentially disease-causing bacteria in IBD.

Looking across four geographically distinct IBD cohorts (n=537), researchers identified a clade of Kp strains, featuring a unique antibiotics-resistance and mobilome signature that were strongly associated with IBD disease exacerbation and severity.

These strains were then transferred into colitis-prone germ-free and colonized mice to enhance intestinal inflammation.

Researchers then demonstrated proof-of-concept assessment of Kp-targeting phages by generating an orally administered, lytic 5-phage combination product specifically designed to target sensitive and resistant IBD-associated Kp clade members through distinct mechanisms.

The lytic 5-phage treatment enabled effective Kp suppression in the colitis-prone mice and drove attenuated inflammation and disease severity.

Furthermore, the research initially tested Kp-targeting phage in an ex-vivo human gut system and then in a first-in-human, randomized, single-blinded, placebo-controlled clinical trial.

Both phage therapies were stable, withstanding shifting biophysical conditions along the human gastrointestinal tract, resulting in accumulation of viable phages in doses expected to enable Kp2 suppression in IBD patients.

IBD is a chronic, inflammatory autoimmune disease impacting the gastrointestinal tract, and the bacteria, Klebsiella pneumoniae, has been implicated in the pathogenesis of the disease.

BiomX's novel phage candidate, BX003, targets bacterial strains of Kp present in the gut of IBD and primary sclerosing cholangitis patients.

As outlined in the research, results from Phase 1a study demonstrated safety and tolerability of the administered phages as well as successful delivery of a high concentration of viable phage to the lower gastrointestinal tract, in alignment with data generated in a human-gut like system.

BX003 is an orally administered phage cocktail targeting a bacterial target present in the gut of IBD and PSC patients and thought to be associated with the onset or exacerbation of these diseases.

Although different organs are affected in IBD and PSC (gut in IBD and liver in PSC) the two diseases are thought to be related since approximately 70% of PSC patients also suffer from IBD.

Results from a pharmacokinetic and safety Phase 1a study demonstrated safety and tolerability with successful delivery of a high concentration of viable phage to the lower gastrointestinal tract.

Currently, the development efforts on BX003 are temporarily paused.

BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases.

BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.
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