Sagimet reports 52‑week Phase 3 acne data showing strong efficacy and safety
Sagimet Biosciences announced that its Phase 3 open‑label extension of denifanstat in 240 Chinese patients achieved a 57% Investigator’s Global Assessment success rate. The study showed a 72% drop in total lesion counts and a 77% drop in inflammatory lesions after 52 weeks, with the drug generally well tolerated. The company is now screening for its U.S. Phase 3 AURORA trial, and the Chinese NDA was accepted by the NMPA in December 2025.
Why it matters
The company says the long‑term results support moving denifanstat into the U.S. trial, which could create a sizable market opportunity if the data translate. Analysts note that positive data may lift SGMT’s share price and improve its valuation prospects.
Key facts
- 1The open‑label extension enrolled 240 patients, of whom 116 had received denifanstat in the prior trial and 124 had received placebo. globenewswire.com
- 2Investigator’s Global Assessment success was observed in 57% of participants at week 52. globenewswire.com
- 3Total lesion counts decreased by 72% after 52 weeks of treatment. globenewswire.com
- 4Inflammatory lesion counts fell by 77% after 52 weeks of treatment. globenewswire.com
- 5The Chinese New Drug Application was accepted by the NMPA in December 2025. globenewswire.com
- 6Sagimet has activated sites and begun patient screening for the U.S. Phase 3 AURORA trial. globenewswire.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.