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Sagimet Biosciences (SGMT) investor relations material
Sagimet Biosciences H.C. Wainwright Liver Disease Virtual Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Scientific focus and differentiation
Developing FASN inhibitors targeting metabolic and fibrotic pathways in diseases like MASH, acne, and certain tumors.
Denifanstat is the only late-stage fat synthesis inhibitor in clinical development, showing significant fibrosis improvement in severe MASH patients.
Combination of denifanstat with resmetirom shows amplified response in MASH markers; phase I PK study underway with results expected in the first half of next year.
Partner Ascletis in China reported statistically significant phase III results in moderate to severe acne; NMPA submission planned.
Mechanism of action and clinical data
FASN inhibition targets fat accumulation, inflammation, and fibrosis in three liver cell types, offering a unique direct effect on stellate cells.
Denifanstat met primary and secondary endpoints in phase II-B FASCINATE-2 trial, showing significant improvements in fibrosis and MASH resolution.
Digital AI pathology and traditional pathology both confirm significant fibrosis improvement, especially in advanced disease (F3/F4 patients).
36% delta over placebo for one-stage fibrosis improvement and 30% for two-stage improvement in F3 patients.
Regulatory and technology landscape
Digital pathology is gaining regulatory acceptance, especially for advanced fibrosis; non-invasive measures like VCTE and FAST score are becoming important endpoints.
FDA has accepted FibroScan technology as a robust surrogate for drug response, aligning clinical practice with regulatory approval.
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