Benzinga | Nov 4, 2020 06:36AM EST

BiomX Announces Dosing Of First Subject In Phase 1a Study Of BX002 Phage Therapy For Inflammatory Bowel Disease

- Study is designed to evaluate safety, pharmacokinetics, and oral delivery of viable phage -

- Results expected in the first quarter of 2021 -

BiomX Inc. (NYSE:PHGE), a clinical stage company developing natural and engineered phage therapies that target specific pathogenic bacteria, today announced that the first subject has been dosed in a Phase 1a study of BX002, a phage therapy candidate for the treatment of inflammatory bowel disease (IBD). The first-in-human study is designed to evaluate the safety, pharmacokinetics, and ability of orally-administered BX002 to deliver viable phage to the gut. The therapy targets strains of Klebsiella pneumoniae that cause strong TH1 immune stimulation and colitis in mouse models of disease and are known to be present at a higher prevalence and abundance in IBD patients relative to healthy individuals.

"This study is an important initial step in advancing phage therapy for IBD, by helping establish an appropriate method for delivering phage to the gastrointestinal tract," commented Jonathan Solomon, Chief Executive Officer of BiomX. "Our goal is to demonstrate successful delivery of viable phage before proceeding to a study designed to measure the reduction of target bacteria. We look forward to announcing the results of this study in the first quarter of 2021."

The randomized, single-blind, multiple-dose, placebo-controlled study in 18 healthy volunteer subjects is designed to evaluate the safety and tolerability of orally administered BX002 as the primary endpoint, with detection of viable phage in stool as a key exploratory endpoint. The study is being conducted in the U.S. under an investigational new drug application approved by the U.S. Food and Drug Administration.