Sagimet To Present Positive Full 52-Week Results from License Partner Ascletis' Phase 3 Open-Label Extension Clinical Trial of Denifanstat in Acne and Mechanistic Data at the 2026 Fall Clinical Dermatology Conference
Key Highlights
- ➤Denifanstat delivered 57% IGA success through 52 weeks in Ascletis’ Phase 3 extension
- ➤Total lesions fell 72% and inflammatory lesions declined 77% through 52 weeks
- ➤Ascletis’ Chinese NDA submission was accepted by NMPA in December 2025
- ➤AURORA U.S. Phase 3 trial is screening patients with sites activated and IRB approvals
- ➤Denifanstat was generally well-tolerated throughout the 52-week open-label extension
Expert Statements
David Happel, Chief Executive Officer of Sagimet
“The data being presented at the Fall Clinical Dermatology Conference highlight the potential and novel role of FASN inhibition to treat patients and families living with acne”
David Happel, Chief Executive Officer of Sagimet
“Denifanstat has demonstrated significant and sustained improvements in moderate to severe acne through 52 weeks of treatment.”
David Happel, Chief Executive Officer of Sagimet
“With AURORA sites activated and patient screening beginning this month, we are excited to be advancing denifanstat into our U.S. Phase 3 program.”
* Denifanstat showed continued improvement and sustained efficacy across all efficacy endpoints through 52 weeks, including 57% IGA success, 72% reduction in total lesions, and 77% reduction in inflammatory lesions, and was generally well-tolerated * Clinical findings and preclinical mechanistic evidence support FASN inhibition as a novel oral therapeutic approach targeting key aspects of acne pathogenesis * AURORA U.S. Phase 3 trial screening patients, with sites activated and IRB approvals in place FOSTER CITY, Calif., Oct. 09, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the positive 52-week clinical results from the Phase 3 ASC40-304 open-label extension of denifanstat in patients with moderate to severe acne vulgaris, conducted by license partner Ascletis BioScience Co. Ltd. (Ascletis) in China, along with mechanistic data, will be presented at the 2026 Fall Clinical Dermatology Conference taking place October 8-11, in Las Vegas, Nevada. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 in China where it holds an exclusive license to denifanstat, and by Sagimet in the rest of the world.
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