Sagimet Announces Positive Full 52-Week Results from License Partner Ascletis' Phase 3 Open-Label Extension Clinical Trial of Denifanstat in Acne Presented at EADV 2026
Key Highlights
- ➤Denifanstat treatment success reached 56.7% after up to 52 weeks
- ➤Total lesion count fell 71.8% from ASC40-303 baseline
- ➤Inflammatory lesion count fell 76.9% from ASC40-303 baseline
- ➤No adverse event-related permanent discontinuations occurred through 52 weeks
- ➤U.S. AURORA Phase 3 patient screening expected to begin in October 2026
Expert Statements
David Happel, Chief Executive Officer of Sagimet
“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.”
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.”
Andreas Grauer, MD, Chief Medical Officer of Sagimet
“The open-label extension trial provides important data to support our AURORA Phase 3 program.”
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.”
Andreas Grauer, MD, Chief Medical Officer of Sagimet
“Notably, patients who crossed over from placebo achieved treatment success rates similar to those treated with denifanstat from the start.”
Andreas Grauer, MD, Chief Medical Officer of Sagimet
“Together, these results provide meaningful long-term experience with the 50 mg denifanstat dose we are taking forward in AURORA.”
* In the Phase 3 open-label extension clinical trial (OLE), patients with moderate to severe acne received denifanstat for up to 52 weeks, including prior placebo patients * Denifanstat showed progressive and sustained improvements across all efficacy endpoints in the OLE, including Investigator's Global Assessment (IGA) success with a response rate of 57%, 72% reduction in total lesions, and 77% reduction in inflammatory lesions, and was generally well-tolerated, with no adverse event-related permanent discontinuations * Patient screening for AURORA U.S. Phase 3 clinical trial expected to begin in October 2026 * Sagimet to host a KOL event and webcast September 30, 2026 at 1 PM ET FOSTER CITY, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- 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.
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