Denifanstat Phase 2b MASH Study Presented at EASL 2024 Congress

Sagimet Biosciences, a company at the forefront of clinical-stage biopharmaceutical research, has made a significant announcement regarding their Phase 2b FASCINATE-2 study. The study, which focuses on metabolic dysfunction-associated steatohepatitis (MASH), will feature a presentation at the European Association for the Study of the Liver (EASL) International Liver Congress 2024 in Milan, Italy. The event is scheduled from June 5th to June 8th, 2024.

The oral presentation will highlight the findings of the FASCINATE-2 study, which investigates the effects of denifanstat, a fatty acid synthase (FASN) inhibitor. The drug has shown promising results in improving fibrosis and resolving MASH in a 52-week international, randomized, double-blind, placebo-controlled trial involving patients with F2 or F3 fibrosis. The presenter of the session will be Dr. Rohit Loomba, an esteemed figure in the field of gastroenterology and hepatology at the University of California San Diego.

Sagimet Biosciences is dedicated to developing innovative FASN inhibitors that target metabolic pathways disrupted by the overproduction of palmitate, a fatty acid. Their flagship drug candidate, denifanstat, is an oral medication taken once daily and is currently under development for the treatment of MASH. The Phase 2b clinical trial, FASCINATE-2, which uses liver biopsy-based primary endpoints, has been completed successfully with positive outcomes.

MASH is a serious and progressive liver condition that is estimated to affect over 115 million individuals globally. In 2023, there was a concerted effort by global liver disease medical societies and patient groups to rename non-alcoholic fatty liver disease (NAFLD) to MASLD and nonalcoholic steatohepatitis (NASH) to MASH. The term SLD was also introduced to encompass various liver diseases associated with fat accumulation in the liver. The aim of these name changes was to establish a more positive and non-stigmatizing nomenclature for these conditions.

The announcement from Sagimet Biosciences is a significant step forward in the ongoing battle against MASH, a disease that has been renamed to reflect its metabolic nature rather than its alcohol-related origins. The company's commitment to developing new treatments for this condition is evident through their successful Phase 2b trial and the upcoming presentation at EASL. With the global liver disease community rallying behind a more inclusive and accurate terminology, the future of MASH treatment and research looks promising.