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.
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.
For the treatment of atopic dermatitis, Technoderma Medicines, Inc. has completed a Phase 1 clinical trial of TDM-180935 topical. This first clinical trial in the AD program included single dose and multidose escalation cohorts in a study entitled, “A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects.” All strengths of TDM-180935 (0.25%-2.0%) were well tolerated with no material safety issues identified. Bioanalytical results show that once daily application of TDM-180935 for 4 weeks over the range of doses studied produces extremely low to no systemic exposure.
TDM 180935 is a small molecule drug candidate that functions as a potent JAK1/Tyk2 small molecule inhibitor.