The board of directors (the "Board") of Ascletis Pharma Inc. announced the dosing of the first patient in the Phase II clinical trial of ASC40 for moderate to severe acne. ASC40 is an oral, selective inhibitor of fatty acid synthase (FASN), a key enzyme which regulates de novo lipogenesis. Human sebum production requires de novo lipogenesis, which is increased in acne and suppressed by the FASN inhibitor ASC40.

The Phase II trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of ASC40 for the treatment of patients with moderate to severe acne. About 180 patients will be randomized into three active treatment arms or one placebo control arm at the ratio of 1:1:1:1 and receive ASC40 (25 mg, 50 mg or 75 mg) or matching placebo orally once a day for 12 weeks. The primary outcomes include percentage change of total lesion count at week 12 compared to baseline and ratio of subjects, whose Investigator's Global Assessment (IGA) grades are decreased by 2 grades at week 12 compared to baseline.

Acne is the eighth most prevalent disease in the world and affects more than 640 million people globally. The onset of acne often coincides with pubertal hormonal changes, and the condition affects approximately 85% of adolescents and young adults aged 12 to 25 years. However, acne can also persist into or develop during adulthood.