Novel Oral Therapy from Ascletis Starts Phase III Trial for Acne

Dec 5, 2023 | Blog, Uncategorized

The Phase III clinical trial is now underway to evaluate fatty acid synthase (FASN) inhibitor ASC40 (Denifanstat) from Ascletis Pharma, Inc. for treatment of moderate to severe acne vulgaris.
The randomized, double-blind, placebo-controlled, multicenter clinical trial being conducted in China will enroll 480 subjects with moderate to severe acne vulgaris randomized to receive oral 50mg ASC40 or matching placebo once daily for 12 weeks.
The co-primary efficacy endpoints are: proportion of subjects achieving treatment success at week 12, percentage change from baseline in total lesion count, and percentage change from baseline in inflammatory lesion count (ILC) at week 12. Treatment success is defined as at least a 2-point reduction in Investigator’s Global Assessment (IGA) score from baseline and a score of clear (0) or almost clear (1).
Ascletis announced in May that ASC40 achieved primary and key secondary endpoints in the Phase II clinical trial for the treatment of acne vulgaris, demonstrating good safety.
ASC40 is an oral, selective small molecule inhibitor of FASN. Ascletis says that mechanisms of ASC40 for treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Ascletis holds the rights to develop, manufacture and commercialize ASC40 in Greater China under an exclusive license from Sagimet Biosciences Inc.

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