Sagimet Biosciences to present Phase 2b data of denifanstat at AASLD 2024

Sagimet Biosciences announced that Phase 2b data demonstrating the anti-fibrotic activity of its fatty acid synthase inhibitor, denifanstat, and preclinical data demonstrating atherosclerosis improvement with FASN inhibitor treatment, will be highlighted in three presentations at the American Association for the Study of Liver Disease – The Liver Meeting 2024, taking place November 15-19, 2024 in San Diego, California. Title: AI-based digital pathology shows that denifanstat improves multiple parameters of fibrosis and reduces progression to cirrhosis in MASH patients with F2/F3 fibrosis – results of the FASCINATE-2 study: Denifanstat, an oral FASN inhibitor, demonstrated statistically significant MASH resolution and fibrosis improvement and decreased liver fat and biomarkers of inflammation and fibrosis in the Phase 2b study FASCINATE-2. AI digital pathology results confirm denifanstat’s reduction of liver fibrosis and steatosis in MASH shown in the FASCINATE-2 study. Title: Fatty acid synthase inhibitor reduces atherosclerosis development in diet-induced dyslipidaemia LDL receptor knockout mice with MASH: In a mouse model of dyslipidaemia and MASH, FASN inhibition by denifanstat not only reduced circulating cholesterol, but also decreased the development of atherosclerosis and improved liver histology. These results suggest that denifanstat, once approved, could potentially offer benefits in both cardiovascular and liver health benefits to patients and support its future clinical evaluation for long term outcomes in MASH patients. Title: Denifanstat significantly improves liver fibrosis in difficult-to-treat metabolic dysfunction-associated steatohepatitis patients. Results from conventional and AI-based pathology from the Phase 2b FASCINATE-2, a 52-week randomized, double blind, placebo-controlled trial of fatty acid synthase inhibitor denifanstat, in F2/F3 MASH: Denifanstat’s impact on fibrosis in the overall Phase 2b study population as well as in difficult-to-treat subsets was evaluated by conventional histopathology and second harmonic generation AI-based digital pathology. Denifanstat demonstrated statistically significant improvement in liver fibrosis without worsening of MASH, including 2-stage fibrosis improvement in difficult-to-treat MASH.