Sagimet Announces Positive 52-Week Results for Denifanstat in Acne Trial
News related to:Sagimet Biosciences Inc · 3 min read
FOSTER CITY, Calif., Sept. 30, 2026 /CourierPR/ -- Sagimet Biosciences Inc. announced positive 52-week results from the Phase 3 open-label extension clinical trial of denifanstat in patients with moderate to severe acne vulgaris. The trial, conducted by license partner Ascletis BioScience Co. Ltd. in China, involved 240 patients who had previously participated in the 12-week randomized, double-blind, placebo-controlled Phase 3 ASC40-303 clinical trial. These patients rolled over into the open-label extension trial, receiving denifanstat for up to 52 weeks.
Denifanstat, an oral small molecule fatty acid synthase (FASN) inhibitor, showed progressive and sustained improvements across all efficacy endpoints. At the end of the trial, 57% of patients achieved treatment success, defined as at least a 2-point reduction from baseline in Investigator's Global Assessment (IGA) score with a score of 0 (clear) or 1 (almost clear). The trial also reported a 72% reduction in total lesions and a 77% reduction in inflammatory lesions. These results were presented at the European Academy of Dermatology and Venereology Congress (EADV) in Vienna by Ascletis.
The trial was generally well-tolerated, with no permanent discontinuations of the study drug due to adverse events. Only two categories of treatment-related adverse events had an incidence of more than 5% over the 52-week period: dry skin in 7.1% and dry eye in 5.9%.
The AURORA Phase 3 clinical trial, intended to enroll approximately 800 U.S. patients aged 12 years and older, is designed to evaluate the efficacy and safety of denifanstat in treating moderate to severe acne. Approximately 450 of these patients are expected to be adolescents aged 12 to 17 years.
Sagimet Biosciences will host a virtual Key Opinion Leader (KOL) event and webcast on September 30, 2026, at 1 PM ET, with Julie Harper, MD, Founding Director and past President of the American Acne and Rosacea Society, to discuss the 52-week data from the Phase 3 open-label extension clinical trial and provide an update on the company's planned U.S. Phase 3 AURORA clinical trial.
The Phase 3 open-label extension trial ASC40-304 (NCT06248008) evaluated the long-term safety of denifanstat in patients with moderate to severe acne vulgaris who were previously enrolled in the double-blind, randomized, placebo-controlled 12-week Phase 3 ASC40-303 trial. This open-label Phase 3 trial enrolled 240 subjects who received oral denifanstat 50 mg once daily for up to 40 weeks. Subjects who were originally randomized to denifanstat in ASC40-303 had a total of up to 52 weeks of denifanstat exposure.
The AURORA multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial of denifanstat in moderate to severe acne is expected to enroll approximately 800 U.S. patients aged 12 years and older, with 450 expected to be adolescents aged 12 to 17 years. The trial will have three co-primary endpoints that will be assessed at week 12: the proportion of patients achieving treatment success in a global assessment score, defined as at least a 2-point reduction from baseline with a score of 0 (clear) or 1 (almost clear); absolute change in inflammatory skin lesion counts from baseline; and absolute change in non-inflammatory skin lesion counts from baseline. A subset of approximately 530 patients completing the double-blind period will be eligible to enter a 40-week open-label extension evaluating the long-term safety of denifanstat.
Denifanstat is an oral, once-daily FASN inhibitor in development for the treatment of moderate to severe acne. In trials conducted by Sagimet’s license partner, Ascletis BioScience Co. Ltd. in China, denifanstat met all primary and secondary endpoints in a 12-week randomized, double-blind Phase 3 clinical trial in moderate to severe acne vulgaris and was generally well-tolerated and showed improvements in all efficacy endpoints measured at 52 weeks in an open-label extension clinical trial evaluating denifanstat’s long-term safety in patients with moderate to severe acne.