SAN MATEO, Calif., Oct. 6, 2020 /PRNewswire/ — Sagimet Biosciences, a clinical-stage biotechnology company, announced today that new results from its Phase 2 FASCINATE-1 trial of TVB-2640 in nonalcoholic steatohepatitis (NASH) will be shared in an oral presentation at The Liver Meeting Digital Experience™ 2020 of the American Association for the Study of Liver Diseases (AASLD) to be held November 13 – 16. In this randomized, placebo-controlled trial, a novel, first-in-class, FASN inhibitor, TVB-2640 significantly decreased liver fat and serum biomarkers of liver injury, fibrosis and inflammation with an excellent safety profile and tolerability.
Rohit Loomba, M.D., M.H.Sc., Director, NAFLD Research Center, University of California San Diego, and Coordinating Principal Investigator of the study, will present the results in an oral presentation entitled “Novel, first-in-class, fatty acid synthase (FASN) inhibitor, TVB-2640 demonstrates clinically significant reduction in liver fat by MRI-PDFF, and ALT in NASH: a Phase 2 randomized placebo-controlled trial (FASCINATE-1).”
“The potent liver fat reduction, measured by an advanced MRI method called MRI-PDFF, combined with the additional biomarkers demonstrates that TVB-2640 is positively impacting multiple pathological mechanisms causing liver damage in NASH patients,” said Dr. Loomba. “MRI-PDFF response is an accurate and reliable biomarker that correlates with histological response in NASH and also has been shown to predict NASH resolution. The treatment response seen in TVB-2640 treated subjects in this study along with the additional biomarkers increases our confidence to embark upon a larger Phase 2b liver biopsy based clinical trial in NASH patients with stage 2-3 fibrosis.”
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