– Primary endpoints are safety and tolerability
– Exploratory endpoints include proof of principle by measurement of C. acnes skin levels
– Clinical data are expected at the end of the first quarter of 2020
Ness Ziona, Israel – Dec. 2, 2019 – BiomX Inc. (NYSE: PHGE), a clinical-stage company developing both natural and engineered phage therapies, today announced that patient recruitment for its cosmetic clinical study of BX001, initiated on Oct. 1, 2019, is complete and that 75 patients have been recruited. BX001 is a topically administered gel comprised of a cocktail of naturally occurring phage targeting Cutibacterium acnes (C. acnes, formerly taxonomically classified as Propionibacterium acnes, or P. acnes), a bacterium implicated in the pathophysiology of acne vulgaris. The primary endpoints of the randomized, double-blind, dose-ranging, vehicle-controlled study are safety and tolerability. Exploratory endpoints include proof of principle by measurement of the effect of BX001 on C. acnes levels. Data from this trial are expected at the end of the first quarter of 2020.
“We’re developing BX001 to improve the appearance of acne-prone skin, a highly-prevalent condition that can have profound social and psychological effects on affected individuals. BX001 comprises phage that target specific bacteria and has the potential for efficient rebalancing of the skin microbiome,” said Jonathan Solomon, CEO of BiomX. “In parallel, we are advancing our pipeline of innovative, targeted phage therapies and expect to have our second product candidate, BX002, enter the clinic in 2020 for the treatment of inflammatory bowel disease.”
BiomX enrolled 75 individuals with mild-to-moderate acne in the ongoing cosmetic clinical study of BX001. Enrolled individuals were randomized into three cohorts: a higher-dose cohort (n=25), a lower dose cohort (n=25), and a placebo cohort (n=25).
For BX001 studies in acne-prone skin, BiomX is working in collaboration with a leading multinational cosmetic company. Acne is estimated to affect approximately 10 percent of the global population, resulting in global annual sales of approximately $4 billion in 2018 of cosmetic products for acne-prone skin.
About Phage Therapy
Bacteriophage, or phage, are viruses that target bacteria and are considered inert to mammalian cells. Phage precisely target and kill specific bacterial species or strains without disrupting other bacteria or the healthy microbiota. All of BiomX’s phage-based product candidates derive from its proprietary platform, which is first used to discover and validate the association of specific bacterial strains with human diseases or conditions, and is then used to develop rationally designed phage combinations (“cocktails”) of naturally occurring or synthetic phage to target pathogenic bacteria. The phage cocktails contain multiple phage with complementary functions optimized through in vitro and in vivo testing.
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 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.
Safe Harbor Language
This press release contains certain “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. 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 our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. You should review additional disclosures we make in our filings with the Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www.sec.gov.
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