Sagimet: Positive Topline Results from Phase 2b Trial of Denifanstat in Biopsy-Confirmed F2/F3 NASH

 Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial of 168 NASH patients with stage 2 or 3 fibrosis

• Primary efficacy endpoints:
  • NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS (NAFLD Activity Score) in 36% of denifanstat-treated patients vs 13% with placebo (p=0.002)
  • ≥2-point reduction in NAS without worsening of fibrosis in 52% of denifanstat-treated patients vs 20% with placebo (p=0.0001)
    
    
• Multiple secondary endpoints:
  
  
  • Fibrosis improvement by ≥ 1 stage with no worsening of NASH in 41% of denifanstat-treated patients vs 18% with placebo (p=0.005)
  • NASH resolution with no worsening of fibrosis in 38% of denifanstat-treated patients vs 16% with placebo (p=0.002)
  • MRI-PDFF decline from baseline ≥30% (responders) in 65% of denifanstat-treated patients vs 21% with placebo (p<0.0001)

Statistically significant improvements in additional markers of liver health, including artificial intelligence (AI) digital pathology-based fibrosis assessment, FAST Score, and ALT, and numerical improvements in LDL

Denifanstat was generally well-tolerated

Management to host live webcast at 8:00 a.m. ET on Monday, January 22, 2024

Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced positive topline results from its FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed non-alcoholic steatohepatitis (NASH) patients with stage 2 or stage 3 fibrosis (F2/F3) at week 52. In this trial, denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements relative to placebo on both of the primary endpoints of NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS, and ≥2-point reduction in NAS without worsening of fibrosis. Denifanstat-treated patients also showed statistically significant fibrosis improvement by ≥ 1 stage with no worsening of NASH, and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo.

Management will host a live webcast at 8:00 a.m. ET on Monday, January 22, 2024 to discuss the data; participants will have the opportunity to participate in a chat-based Q&A session. The webcast will be available here and in the Events & Presentation section of Sagimet’s website at www.sagimet.com, with an archived replay available for approximately 90 days following the event.

https://www.globenewswire.com/news-release/2024/01/22/2812908/0/en/Sagimet-Biosciences-Announces-Positive-Topline-Results-from-Phase-2b-FASCINATE-2-Clinical-Trial-of-Denifanstat-in-Biopsy-Confirmed-F2-F3-NASH.html