Sagimet reports 52-week denifanstat acne trial results
- Sagimet Biosciences (NASDAQ:SGMT) reported 52-week results from Ascletis’ Phase 3 open-label extension trial of denifanstat in moderate to severe acne.
- The study included 240 patients, with treatment success reaching 56.7% after 52 weeks of denifanstat exposure.
- Sagimet stated that screening for its U.S. AURORA Phase 3 trial is expected to begin in October 2026 using the 50 mg dose.
Sagimet Biosciences (NASDAQ:SGMT) announced 52-week results from license partner Ascletis’ Phase 3 open-label extension trial of denifanstat in moderate to severe acne, with treatment success reaching 56.7% among 240 patients.
The China-based trial included 116 patients previously treated with denifanstat and 124 patients previously given placebo during a 12-week trial, before both groups received denifanstat during the 40-week extension period.
At the end of the 52-week extension, mean total lesion counts declined 71.8% from the original trial baseline, while inflammatory and non-inflammatory lesion counts declined 76.9% and 66.9%, respectively, with no drug-related serious adverse events reported.
The company reported that treatment-related dry skin affected 7.1% of patients and dry eye affected 5.9%, while no patients permanently discontinued treatment due to adverse events.
Sagimet is developing denifanstat as a potential treatment for acne and other metabolic-driven conditions, with the company planning to begin screening for its U.S. AURORA Phase 3 trial in October 2026 and enroll its first patient shortly afterward.
