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Denifanstat Achieved All Endpoints in the Treatment of Moderate to Severe Acne in Phase 3 Clinical Trial in Acne in China: A Presentation at the 2025 Fall Clinical Dermatology Conference
Denifanstat met all primary and secondary endpoints versus placebo and was generally well tolerated in a Phase 3 clinical trial in acne in China conducted by
About this update from Sagimet Biosciences Inc. - Series A
[{"type":"text","content":"Denifanstat met all primary and secondary endpoints versus placebo and was generally well tolerated in a Phase 3 clinical trial in acne in China conducted by license partner Ascletis Ascletis announced completion of its pre-NDA consultation with China’s NMPA and its plans to submit an NDA for denifanstat in China SAN MATEO, Calif., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported that data from a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), will be presented at the 2025 Fall Clinical Dermatology Conference taking place October 24-26, 2025, in Las Vegas, Nevada. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for MASH in the rest of world. The Phase 3 clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat for the treatment of patients with moderate to severe acne, defined as Investigator’s Global Assessment (IGA) scores of 3 and 4. This trial enrolled 480 patients who were randomized 1:1 into two treatment arms to receive denifanstat 50mg or placebo, once daily for 12 weeks. Primary endpoints included the percentage of treatment success (defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline), the percentage change in total lesion count, and the percentage change in inflammatory lesion count. Denifanstat met all primary and secondary endpoints and was generally well tolerated. In October, Ascletis announced that it completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon. 2025 Fall Clinical Dermatology Conference Poster Presentation Details: Title:FASN Inhibitor Denifanstat Achieved All Endpoints in the Treatment of Acne Vulgaris: Results from a Phase III Randomised Placebo-Controlled TrialPresenting authors:Neal Bhatia, MD, FAAD, D...