3 December 2019 - - Patient recruitment for Israel-based clinical-stage company BiomX Inc.'s (NYSE: PHGE) cosmetic clinical study of BX001, initiated on Oct. 1, 2019, is complete and that 75 patients have been recruited, the company said.

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 1Q20.

BiomX enrolled 75 individuals with mild-to-moderate acne in the ongoing cosmetic clinical study of BX001. Enrolled individuals were randomised into three cohorts: a higher-dose cohort, a lower dose cohort, and a placebo cohort.

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 % of the global population, resulting in global annual sales of approximately USD4 bn in 2018 of cosmetic products for acne-prone skin.

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 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, primary sclerosing cholangitis, and colorectal cancer.

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