Ascletis Pharma has announced the dosing of the first patient in the Phase II clinical trial of ASC40 for moderate to severe acne.
Ascletis is a R&D biotech company committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC and cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors) to address unmet medical needs in China and around the world.
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.
The trial will include about 180 patients randomized into three active treatment arms or one placebo control arm at the ratio of 1:1:1:1. Patients receive ASC40 (25 mg, 50 mg or 75 mg) or matching placebo orally once a day for 12 weeks. The trial outcomes include changes in the 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.
"We have observed that ASC40 inhibited human facial sebum production in the Phase I clinical study. Based on the underlying mechanism of action of ASC40, I am looking forward to the data from this phase II study for the treatment of acne," said Dr. Jinzi J. Wu, founder, chairman and CEO of Ascletis.