– Study is designed to evaluate safety, pharmacokinetics, and oral delivery of viable phage –
– Results expected in the first quarter of 2021 –
Ness Ziona, Israel – Nov. 3, 2020 – BiomX Inc. (NYSE American: 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.
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 harmful bacteria in chronic diseases, such as inflammatory bowel disease (IBD), primary sclerosing cholangitis (PSC), and colorectal cancer (CRC). BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.
Additional information is available at www.biomx.com.
Safe Harbor Language
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX discusses the potential of BX002 and phage therapy to help establish an appropriate method for delivering phage to the gastrointestinal tract, the design of the Phase 1a study and the desired results thereof and the timing of the results of the Phase 1a study, BiomX is making forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, invest should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q and additional disclosures BiomX makes in its filings with the Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.
Noel Kurdi, BiomX
VP Investor Relations and Strategy
Rich Allan, Solebury Trout