FOSTER CITY, Calif. — September 28, 2026
Sagimet Biosciences Inc. announced that it will host a virtual key opinion leader (KOL) event on September 30, 2026, featuring dermatologist Julie Harper, MD, to discuss 52-week data from Ascletis’ Phase 3 open-label extension study of denifanstat in moderate to severe acne vulgaris in China and provide an update on Sagimet’s planned U.S. Phase 3 AURORA trial. The event will include a presentation from Dr. Harper, a founding director and past president of the American Acne and Rosacea Society, followed by a live question-and-answer session with company management. Sagimet said the 52-week data showed improvements across all measured efficacy endpoints beyond the results observed at 12 weeks in the original randomized clinical trial, while denifanstat remained generally well tolerated. The detailed findings are expected to be presented at EADV 2026, as Sagimet prepares to initiate its U.S. Phase 3 program.
Denifanstat Shows Longer-Term Improvements in China Study
Denifanstat demonstrated continued improvement across efficacy measures during the 52-week open-label extension of the Phase 3 acne study conducted by Sagimet’s license partner Ascletis in China. The extension followed a 12-week randomized, double-blind Phase 3 trial in patients with moderate to severe acne vulgaris. According to Sagimet, participants treated with denifanstat showed improvements in all efficacy endpoints assessed at 52 weeks, which were secondary endpoints of the overall development program. Denifanstat was also reported to be generally well tolerated during both the original controlled trial and the open-label extension. The longer-term findings are intended to provide additional information on durability and safety as Sagimet prepares its global development strategy. However, because the 52-week extension is open-label, the longer-term efficacy observations should be interpreted differently from results generated in a randomized placebo-controlled comparison.
AURORA Phase 3 Trial Targets U.S. Acne Patients
Sagimet expects to initiate the AURORA Phase 3 clinical trial in the United States during the fourth quarter of 2026, evaluating denifanstat in approximately 800 patients aged 12 years and older with moderate to severe acne. The multicenter, randomized, double-blind, placebo-controlled study will randomize participants 2:1 to denifanstat 50 mg or placebo once daily for 12 weeks. The trial has three co-primary endpoints: treatment success based on global assessment, absolute change in inflammatory lesion counts and absolute change in non-inflammatory lesion counts at Week 12. Approximately 530 participants who complete the double-blind period are expected to be eligible for a subsequent 40-week open-label extension designed to evaluate longer-term safety. The program is intended to generate controlled U.S. clinical data for denifanstat as Sagimet expands development of the once-daily oral therapy in moderate to severe acne.
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Sagimet Advances FASN Inhibitor Development
Denifanstat is an investigational oral fatty acid synthase (FASN) inhibitor designed to target lipid metabolism and dysfunctional metabolic pathways associated with acne and other diseases. FASN regulates lipid synthesis and is implicated in the production of palmitate, a fatty acid involved in several biological pathways. In China, Ascletis is developing denifanstat as ASC40, while Sagimet is responsible for development outside China. The company is also investigating FASN inhibition in other conditions, including metabolic dysfunction-associated steatohepatitis (MASH) and selected FASN-dependent tumor types. Sagimet’s upcoming KOL event is expected to provide additional context on the 52-week acne data and the design of the AURORA study as the company moves toward another late-stage clinical evaluation of denifanstat. The program remains investigational, and future controlled Phase 3 results will be needed to establish its efficacy and safety in the U.S. population.
Source Sagimet Biosciences press release
