ASC40 (denifanstat) - (AURORA)

October 9, 2026: Sagimet Biosciences (NASDAQ: SGMT) said positive 52-week Phase 3 open-label extension results for denifanstat in moderate to severe acne vulgaris, generated by partner Ascletis in China, will be presented at the 2026 Fall Clinical Dermatology Conference (October 8-11, Las Vegas). In the ASC40-304 extension, denifanstat was generally well tolerated and showed continued efficacy through 52 weeks, including 57% IGA success, 72% reduction in total lesions, and 77% reduction in inflammatory lesions.

The extension enrolled 240 patients rolling over from the 12-week randomized, placebo-controlled Phase 3 ASC40-303 study; 116 had previously received denifanstat and 124 placebo. The earlier 480-patient ASC40-303 trial met all primary and secondary endpoints and was generally well tolerated, with significant improvements reported as early as 4 weeks.

The conference presentation will also include mechanistic data supporting fatty acid synthase (FASN) inhibition, including reduced sebum lipids in vitro and in vivo. Ascletis’ China NDA for denifanstat was accepted by the NMPA in December 2025.

Sagimet also said its U.S. Phase 3 AURORA trial is beginning, with sites activated, IRB approvals in place, and patient screening starting in October 2026. AURORA plans to enroll about 800 U.S. patients and assess three co-primary endpoints at week 12.