The Phase 2 cosmetic clinical study is planned to be a 12-week randomized, double-blind, placebo-controlled trial in 100 individuals with mild-to-moderate acne.

BiomX Inc.’s lead candidate BX001 for acne-prone skin met its primary endpoint of safety and tolerability for both doses of BX001 as well as a statistically significant reduction of Cutibacterium acnes (C. acnes) levels for the high dose of BX001 compared to placebo, according to a Phase 1 study.

BX001 is a topical gel comprised of a cocktail of naturally occurring phage targeting C. acnes to improve the appearance of acne-prone skin.

“We are excited to announce positive data demonstrating for the first time that this topically applied phage cocktail, developed through our proprietary discovery platform, showed activity against a bacterial target and was able to demonstrate a statistically significant reduction in C. acnes levels on the skin in a safe and tolerable manner. These results warrant advancing the program to a Phase 2 study,” says Jonathan Solomon, CEO of BiomX, in a news release. “We are carrying out additional analyses on the BX001 clinical data, as well as evaluating the implications of the ongoing COVID-19 pandemic on our clinical development timelines, and intend to provide an update on the timing of the Phase 2 trial when we report our first quarter 2020 financial results.”

The Phase 1 cosmetic clinical study was a four-week randomized, double-blind, dose-finding, placebo-controlled single-center trial which enrolled 75 individuals with mild-to-moderate acne. Enrolled individuals were randomized into one of three cohorts: a high dose cohort, a low dose cohort, and a placebo cohort (vehicle).

Following application of the gel once daily for four weeks, measurement of C. acnes levels using qPCR showed a statistically significant reduction of C. acnes levels in the high-dose cohort of BX001 compared to placebo (p=0.036) at week five (one week after end of treatment), the final study time point. At this time point, a 0.12 log reduction, which translates to a 24 percent reduction in C. acnes levels, was observed in the high dose cohort compared to baseline, while a 0.1 log increase, which translates to a 26 percent increase from baseline, was observed in the placebo cohort. As anticipated for a relatively short-duration study of four weeks, exploratory endpoints measuring reductions in inflammatory and non-inflammatory lesions

The Phase 2 cosmetic clinical study is planned to be a 12-week randomized, double-blind, placebo-controlled trial in 100 individuals with mild-to-moderate acne. Enrolled individuals will be randomized into one of two cohorts: BX001 or placebo (vehicle).

More about phage

Bacteriophage, or phage, are viruses that target bacteria and are considered inert to mammalian cells. Phage are designed to 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 and biologic rationale 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.