Sagimet reports positive 52‑week results from denifanstat acne trial
Sagimet Biosciences announced that the open‑label extension of its Phase 3 denifanstat study in moderate‑to‑severe acne showed 57% Investigator’s Global Assessment success and large reductions in lesion counts through 52 weeks. The trial, run by license partner Ascletis in China, enrolled 240 patients, of whom 116 had previously received denifanstat and 124 had received placebo. Sagimet said its U.S. Phase 3 AURORA trial has activated sites and begun patient screening.
Why it matters
The company says the data support advancement of denifanstat toward U.S. regulatory approval, which could create a new oral acne therapy and drive SGMT’s valuation. The positive efficacy and safety signals may also strengthen the pending Chinese NDA, which was accepted in December 2025.
Key facts
- 157% of patients achieved Investigator’s Global Assessment success at 52 weeks. globenewswire.com
- 2Total lesion count was reduced by 72% at 52 weeks. globenewswire.com
- 3Inflammatory lesion count was reduced by 77% at 52 weeks. globenewswire.com
- 4240 patients rolled over into the open‑label extension trial. globenewswire.com
- 5116 patients had received denifanstat in the prior trial and 124 had received placebo. globenewswire.com
- 6Ascletis submitted a New Drug Application to the NMPA in December 2025. globenewswire.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.