Sagimet reports 57% IGA success at Week 52
- Sagimet Biosciences (NASDAQ:SGMT) reported 52-week acne data showing 57% Investigator’s Global Assessment success with denifanstat.
- Total lesion counts fell 72% and inflammatory lesions declined 77% from baseline in Ascletis’ Phase 3 extension study.
- Sagimet said its U.S. Phase 3 AURORA trial is screening patients, while Ascletis’ China approval application remains under review.
Sagimet Biosciences (NASDAQ:SGMT) reported 52-week denifanstat acne results from license partner Ascletis’ Phase 3 extension study, including 57% Investigator’s Global Assessment success.
Total acne lesions declined 72% from baseline, while inflammatory lesions fell 77%, with efficacy measures continuing to improve through Week 52.
Sagimet said denifanstat was generally well tolerated during the open-label extension, which followed a 12-week placebo-controlled study.
Safety was the primary endpoint of the China extension study, while efficacy measures including lesion counts and IGA response were secondary endpoints.
Clinical and mechanistic data are being presented at the Fall Clinical Dermatology Conference in Las Vegas from October 8 through October 11, 2026.
Ascletis’ application for denifanstat approval in China was accepted in December 2025 and remains under regulatory review.
Sagimet said its U.S. Phase 3 AURORA acne trial is currently screening patients, with sites activated and institutional review board approvals in place.
