other material
confidence high
sentiment positive
materiality 0.80
Sagimet reports positive Phase 2b MASH data for denifanstat; primary endpoints met
Sagimet Biosciences Inc.
- Primary endpoints achieved: ≥2-point NAS reduction without fibrosis worsening (38% vs 16%, p=0.0035) and MASH resolution (26% vs 11%, p=0.0173) in ITT.
- Fibrosis improvement ≥1 stage without MASH worsening: ITT 30% vs 14% (p=0.0199); F3 subgroup 49% vs 13% (p=0.0032).
- Fibrosis improvement ≥2 stages: mITT 20% vs 2% (p=0.0065); F3 34% vs 4% (p=0.0050).
- No treatment-related SAEs; discontinuation rate 19.6% denifanstat vs 5.4% placebo.
- Company plans to initiate Phase 3 registrational program for denifanstat in MASH in H2 2024.