ASCLETIS-B(01672) strategic partner Sagimet announces that the first patient has been dosed in the U.S. Phase III clinical trial of denifanstat (ASC40) for the treatment of moderate-to-severe acne

ASCLETIS-B(01672) announces that its strategic partner Sagimet Biosciences Inc. (Sagimet), a clinical-stage biopharmaceutical company dedicated to developing fatty acid synthase (FASN, a key regulator of lipid synthesis) inhibitors for acne, has completed dosing of the first patient in its pivotal U.S. Phase III clinical trial AURORA of denifanstat (ASC40), which is being conducted in adults and adolescents aged 12 and older with moderate-to-severe acne. AURORA is designed to support a potential U.S. New Drug Application (NDA) submission. The trial builds on the positive Phase III clinical results obtained by Ascletis and its subsequent 52-week open-label extension study data. Under the exclusive license agreement with Sagimet, Ascletis holds the rights to develop, manufacture, and commercialize denifanstat (ASC40) in Greater China. Ascletis has obtained from Sagimet the exclusive license to denifanstat (ASC40) in Greater China.