Sagimet Reports Sustained Acne Improvements With Denifanstat Through 52 Weeks
(RTTNews) - Sagimet Biosciences Inc. (SGMT) announced positive 52-week results from a Phase 3 open-label extension study of denifanstat in patients with moderate-to-severe acne vulgaris. The data, generated by its license partner Ascletis BioScience in China, will be presented at the 2026 Fall Clinical Dermatology Conference.
The ASC40-304 study evaluated the long-term safety and efficacy of denifanstat, an investigational once-daily oral fatty acid synthase (FASN) inhibitor. A total of 240 patients who completed the preceding 12-week Phase 3 ASC40-303 trial entered the extension study.
After up to 52 weeks of treatment, patients showed continued improvements across efficacy measures. Results included a 57% Investigator's Global Assessment (IGA) success rate, a 72% reduction in total acne lesions and a 77% reduction in inflammatory lesions. Denifanstat was generally well tolerated during the study.
Mechanistic research presented alongside the clinical findings showed that FASN inhibition reduced sebum lipids in laboratory studies and clinical trial participants. The findings suggest that denifanstat may address key aspects of acne development by reducing lipid production, sebum and inflammation.
Sagimet said the clinical and mechanistic data support FASN inhibition as a potential new oral treatment approach for moderate-to-severe acne.
Meanwhile, the company's U.S. Phase 3 AURORA trial is screening patients, with clinical sites activated and institutional review board approvals in place. The study is expected to enroll approximately 800 patients aged 12 years and older and will evaluate denifanstat 50 mg once daily against placebo over 12 weeks.
Denifanstat is being developed by Ascletis as ASC40 in China and by Sagimet in other markets. Ascletis submitted a New Drug Application in China in 2025, while Sagimet advances the treatment through its U.S. clinical program.
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