Sagimet Biosciences Presented Data From FASCINATE-2 Phase 2B Trial Of Denifanstat Versus Placebo In Biopsy-Confirmed Metabolic Dysfunction-Associated Steatohepatitis Patients At The European Association For The Study Of The Liver Congress
$SGMT
Biotechnology: Pharmaceutical Preparations
Health Care
- Denifanstat achieved statistically significant results on primary and secondary liver biopsy endpoints in the ITT population, including both histology endpoints recommended in the FDA draft guidance for accelerated approval in MASH.
- Denifanstat showed a statistically significant improvement in liver fibrosis ≥1-stage without worsening of MASH in the ITT population, including in patients with baseline stage 3 fibrosis
- Statistical significance also shown in improvement of liver fibrosis ≥2-stage without worsening of MASH in the mITT population, including in patients with baseline stage 3 fibrosis
- Tripalmitin, a biomarker of denifanstat activity, showed an early and sustained reduction in de novo lipogenesis at 4-weeks
- Safety in the ITT population showed denifanstat was generally well tolerated