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Sagimet Biosciences Announces Publication of Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 MASH in The Lancet Gastroenterology & Hepatology
Sagimet Biosciences Inc. (Nasdaq: SGMT) announced the publication of results from their Phase 2b FASCINATE-2 clinical trial of denifanstat in The Lancet Gastroenterology & Hepatology. The trial, conducted on patients with biopsy-confirmed metabolic-dysfunction associated steatohepatitis (MASH) and stage 2 or 3 fibrosis, showed statistically significant and clinically meaningful improvements in disease activity, MASH resolution, and fibrosis.
Key findings include:
36% of denifanstat-treated patients achieved MASH resolution without worsening of fibrosis (vs 13% with placebo)
Key findings include:
36% of denifanstat-treated patients achieved MASH resolution without worsening of fibrosis (vs 13% with placebo)
52% of denifanstat-treated patients showed ≥2-point reduction in NAS without worsening of fibrosis (vs 20% with placebo)
41% of denifanstat-treated patients demonstrated fibrosis improvement by ≥ 1 stage without worsening of steatohepatitis (vs 18% with placebo)
The results support the advancement of denifanstat into Phase 3 development, with Sagimet planning to start their Phase 3 program in 2024.
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