Why Is Fatty Liver Disease Focused Sagimet Biosciences Stock Shooting Higher Today?

Sagimet Biosciences Inc SGMT announced topline results from its FASCINATE-2 Phase 2b 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. 

Denifanstat showed statistically significant improvements relative to placebo on both of the primary endpoints of NASH resolution without worsening fibrosis, with ≥2-point reduction in NAS and ≥2-point reduction in NAS without worsening of fibrosis. 

• 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)

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. Denifanstat was generally well-tolerated.

• 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).

“Denifanstat is designed to reduce the three main drivers of NASH, including fat accumulation, inflammation, and fibrosis, both independently and in parallel. The week 52 biopsy results showed that denifanstat achieved statistical superiority over placebo in reduction of fibrosis, via two independent processes of traditional histopathology and AI digital pathology,” said Dave Happel, Chief Executive Officer of Sagimet. 

Price Action: SGMT shares are up 136.02% at $16.10 on the last check Monday.