Ascletis Pharma Inc., (HKG: 1672) a China-based biotechnology company, has announced the commencement of a Phase III trial for its drug candidate denifanstat (ASC40), intended to assess its efficacy in treating severe acne vulgaris. The trial, a randomized, double-blind, placebo-controlled, and multi-center study, will be conducted at hospitals across China, with Huashan Hospital in Shanghai leading the initiative, and is expected to enroll 480 patients.
Patients will receive a 50mg dose of ASC40 or a matching placebo orally once daily for 12 weeks. The co-primary efficacy endpoints are the proportion of subjects achieving treatment success at week 12, the percentage change from baseline in total lesion count, and the percentage change from baseline in inflammatory lesion count (ILC) at week 12.
ASC40 is an oral, selective small-molecule inhibitor of fatty acid synthase (FASN) that has shown positive results in Phase II trials as a treatment for acne. The drug’s mechanism of action against acne includes directly inhibiting facial sebum production by suppressing de novo lipogenesis in human sebocytes and broadly inhibiting inflammation through the reduction of cytokine secretion and Th17 differentiation. Ascletis holds the rights to develop, manufacture, and commercialize ASC40 in Greater China under an agreement with Sagimet Biosciences Inc., a US-based company.- Flcube.com
