Sagimet Biosciences Inc ( SGMT ) presented data from its FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) patients at the European Association for the Study of the Liver (EASL) Congress.

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Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for MASH.

Topline data was announced for the FASCINATE-2 Phase 2b study in January.

In the EASL presentation, additional 52-week ITT and F3 subgroup efficacy data included:

The primary endpoint of ≥2-point reduction in NAS (NAFLD Activity Score) without worsening of fibrosis (16% placebo vs 38% with denifanstat) or MASH resolution with ≥2-point reduction in NAS resolution without worsening of fibrosis (11% placebo vs 26% with denifanstat).

Secondary endpoints of fibrosis improvement by ≥ 1 stage with no worsening of MASH (14% placebo vs. 30% with denifanstat) and F3 (13% placebo vs. 49% with denifanstat), and fibrosis improvement by ≥ 2 stages with no worsening of MASH in the mITT (2% placebo vs 20% with denifanstat) and F3 (4% placebo vs 34% with denifanstat) populations.

Data on the increase in beneficial polyunsaturated triglycerides at the end of 52 weeks of treatment (-4% placebo vs +42% denifanstat, p