Phase II clinical trials of a topical bacteriophage-based skin care product for acne-prone skin are planned to begin this year.
BX001, a cocktail of natural bacteriophages specific for Cutibacterium acnes in a topical gel, was developed by an Israeli company specializing in phage therapy. In 2020, the company announced the successful completion of a phase I placebo-controlled clinical trial: BX001, applied twice daily, demonstrated safety and a statistically significant reduction in C. acnes levels on the skin compared to placebo.
Acne is an inflammatory skin condition that develops as a result of various factors affecting the skin's microbiota. Specifically, acne is caused by excess sebum secretion due to various hormonal surges and clogged pores due to hyperkeratinization. These factors create favorable conditions for the proliferation of C. acnes , which in turn causes inflammation of the sebaceous and pilosebaceous follicles.
Traditionally, topical or systemic antibiotics have been used to treat acne, but the proportion of C. acnes strains that are resistant to topical antimicrobials is increasing every year.
The BX001 phage cocktail is designed to kill C. acnes , including antibiotic-resistant strains. The drug does not affect other bacteria that live on the skin and may be important for its normal functioning. The drug is also capable of penetrating biofilms that bacteria can form in hair follicles, making them significantly less accessible to antibiotics.