Sagimet Biosciences Inc. (NASDAQ:SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced positive 52-week results from the Phase 3 ASC40-304 OLE clinical trial of denifanstat in patients with moderate to severe acne vulgaris, conducted by license partner Ascletis BioScience Co. Ltd. (Ascletis) in China. The results were presented at the European Academy of Dermatology and Venereology Congress (EADV) in Vienna by Ascletis. 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.

The Phase 3 OLE clinical trial, ASC40-304, evaluated the long-term safety of denifanstat in patients with moderate to severe acne vulgaris who were previously enrolled in the 12-week randomized, double-blind, placebo-controlled Phase 3 ASC40-303 clinical trial, conducted in China by Ascletis. 240 patients rolled over into the OLE trial, for a total trial duration of up to 52 weeks. 116 of those patients had received denifanstat, and 124 patients had received placebo in the original 12-week double-blind ASC40-303 trial. Primary endpoints evaluated safety, and secondary endpoints evaluated efficacy, including reduction in IGA from baseline and reduction in total lesion count and inflammatory lesion count from baseline.

Denifanstat was generally well-tolerated in the OLE with patients receiving up to 52 weeks of exposure, with no permanent discontinuations of study drug due to adverse events and no drug-related serious adverse events among patients treated with denifanstat. 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 positive results presented today at EADV reinforce our confidence in denifanstat as we prepare to begin patient screening for our U.S. AURORA Phase 3 clinical trial in October, with first patient enrollment expected shortly thereafter," said David Happel, Chief Executive Officer of Sagimet. "Annually approximately ten million people in the U.S. live with moderate to severe acne. Denifanstat, if approved, could offer a convenient, once-daily oral medication for this underserved patient population, and would be the first oral treatment with a novel mechanism of action approved for acne in more than forty years."

"The open-label extension trial provides important data to support our AURORA Phase 3 program," said Andreas Grauer, MD, Chief Medical Officer of Sagimet. "It is particularly encouraging that patients continued to improve with longer treatment, and denifanstat remained generally well-tolerated through the open-label extension trial, with exposure to denifanstat up to 52 weeks. Notably, patients who crossed over from placebo achieved treatment success rates similar to those treated with denifanstat from the start. Together, these results provide meaningful long-term experience with the 50 mg denifanstat dose we are taking forward in AURORA."

Virtual Key Opinion Leader Conference Call Information

Sagimet Biosciences will host a virtual KOL event with Julie Harper, MD, Founding Director and past President of the American Acne and Rosacea Society on September 30, 2026 at 1 PM ET.

Dr. Harper will join company management for a review of the 52-week data from license partner Ascletis’ Phase 3 open-label extension clinical trial of denifanstat in moderate to severe acne vulgaris in China and an update on the company’s planned U.S. Phase 3 AURORA clinical trial of denifanstat for the treatment of moderate to severe acne.