3 February 2021 - - Israel-based clinical stage company BiomX Inc. (NYSE American: PHGE) has released positive results of a first-in-human Phase 1a pharmacokinetic study of BX002, the company said.

BX002 is BiomX's orally administered phage therapy candidate targeting Klebsiella pneumoniae (K. pneumoniae) bacteria in the gut, which have been linked to the pathogenesis of both inflammatory bowel disease and primary sclerosing cholangitis.

In the Phase 1a study, BX002 was demonstrated to be safe and well-tolerated, with no serious adverse events and no adverse events leading to discontinuation.

In addition, the study met its objective of delivering high concentrations of viable phage to the gastrointestinal tract of approximately 1010 PFU (plaque forming units).

This equals approximately 1,000 times more viable phage compared to the bacterial burden of K. pneumoniae in IBD and PSC patients as measured in stool.

Based on the Phase 1a study results, BiomX plans to advance to a Phase 1b/2a study evaluating the efficacy of BX003 for the reduction of K. pneumoniae in individuals that carry the target bacteria.

In November 2020, BiomX announced the consolidation of its IBD and PSC programs to develop one product candidate with a broad host range for both indications, designated BX003.

Results from the Phase 1b/2a study are expected by mid-2022.

The randomized, single-blind, multiple-dose, placebo-controlled Phase 1a pharmacokinetic study was conducted under an investigational new drug application approved by the US Food and Drug Administration.

The study evaluated the safety and tolerability of orally administered BX002 in 18 healthy volunteers. Subjects were randomized to receive orally either BX002 or placebo, twice daily for three days.

Subjects were monitored for safety for seven days in a clinical unit, with follow-up for safety assessments done at 14 and 28 days after completion of dosing.

Viable phage were detected at high concentrations in samples from all subjects in the BX002 group, compared to no detected levels prior to treatment.

BiomX is a clinical-stage biotechnology company developing both natural and engineered phage cocktails designed to target and destroy bacteria that affect the appearance of skin, as well as target bacteria in the treatment of chronic diseases, such as inflammatory bowel disease, primary sclerosing cholangitis, cystic fibrosis and colorectal cancer.

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