Sagimet Biosciences’ Denifanstat Shows Fibrosis Improvement in Phase 2b Study for Advanced Fibrosis Patients

October 7, 2025 — Leads & Copy — Sagimet Biosciences Inc. (Nasdaq: SGMT) announced that analyses of the Phase 2b FASCINATE-2 study, demonstrating fibrosis improvement with denifanstat in advanced fibrosis patients, will be presented at The Liver Meeting® 2025 in Washington, DC, November 7-11, 2025.

The abstract has been selected as a Poster of Distinction. The analysis revealed denifanstat’s anti-fibrotic effect via conventional and AI-based digital pathology, identifying a MASH patient subgroup with advanced baseline fibrosis (qF4). Results showed that denifanstat reduced fibrosis and improved multiple non-invasive test (NIT) biomarkers.

Sagimet is a biopharmaceutical company focused on developing fatty acid synthase (FASN) inhibitors. Its lead drug candidate, denifanstat, is an oral FASN inhibitor for metabolic dysfunction-associated steatohepatitis (MASH). The FDA has granted Breakthrough Therapy designation to denifanstat for non-cirrhotic MASH with moderate to advanced liver fibrosis. Sagimet has also initiated a Phase 1 PK clinical trial of a combination of denifanstat and resmetirom, and a Phase 1 first-in-human clinical trial with TVB-3567 for acne in the U.S.

MASH is a severe liver disease impacting over 265 million people globally, characterized by fat build-up, inflammation, fibrosis, and metabolic changes. Patients with advanced fibrosis or cirrhosis have a higher risk of liver-related outcomes. There are few approved treatments for non-cirrhotic MASH and none for MASH cirrhosis.

Investor Contact: Joyce Allaire, LifeSci Advisors, JAllaire@LifeSciAdvisors.com

Media Contact: Michael Fitzhugh, LifeSci Advisors, mfitzhugh@lifescicomms.com

Source: Sagimet Biosciences

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