other material
confidence high
sentiment positive
materiality 0.85
Sagimet reports positive FASCINATE-2 Phase 2b data; denifanstat meets primary endpoints in MASH
Sagimet Biosciences Inc.
- Primary endpoint: MASH resolution with ≥2-point NAS reduction without worsening fibrosis: 38% denifanstat vs 16% placebo (p=0.0035) in ITT.
- Fibrosis improvement ≥1 stage without worsening MASH: 30% vs 14% placebo (p=0.0199) in ITT; 49% vs 13% in F3 subgroup (p=0.0032).
- Fibrosis improvement ≥2 stages in mITT: 20% vs 2% placebo (p=0.0065); 34% vs 4% in F3 subgroup (p=0.0050).
- No treatment-related SAEs; most AEs mild/moderate. TEAE discontinuation 19.6% denifanstat vs 5.4% placebo.
- Company plans to initiate Phase 3 registrational program for denifanstat in MASH with fibrosis in H2 2024.