New York, January 23, 2024 - PrismMarketView - Shares in Sagimet Biosciences Inc. (Nasdaq: SGMT) soared 170% on Monday after the biopharmaceutical company announced positive topline results from its Phase 2b FASCINATE-2 clinical trial evaluating denifanstat versus placebo in non-alcoholic steatohepatitis (NASH) patients. Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial of 168 NASH patients with stage 2 or 3 fibrosis.
Around 24% of US adults have non alcoholic fatty liver disease (NAFLD) and between 1.5% and 6.5% have NASH. One-third of NASH patients go on to develop cirrhosis, which increases the risk of developing liver cancer. Denifanstat is designed to reduce the three main drivers of NASH, including fat accumulation, inflammation, and fibrosis.
Rohit Loomba, M.D., M.H.Sc., Professor of Medicine, Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego, who serves as a scientific advisor for Sagimet on its ongoing development of denifanstat, said, “Denifanstat is the only FASN inhibitor currently in clinical development for the treatment of NASH with related fibrosis. These data show that blocking fatty acid synthesis in the liver and DNL is a critical approach for NASH resolution and improvements in fibrosis. These results support denifanstat’s mechanism of action and the impact of addressing these multiple pathways simultaneously. Moreover, the safety profile supports the further development of denifanstat in NASH patients.”
Highlights
The Phase 2b FASCINATE-2 clinical trial was a 52-week randomized, double-blind, placebo-controlled trial that evaluated the safety and histological impact of denifanstat compared to placebo in 168 biopsy-confirmed NASH patients with moderate-to-severe fibrosis.
Patients were randomized 2:1 to receive 50 mg denifanstat or placebo, taken orally once daily. An end-of-trial biopsy was assessed by a central pathologist for histological endpoints.
In the trial, Denifanstat showed statistically significant improvements relative to placebo on both of the primary endpoints of NASH resolution without worsening of fibrosis with ≥2-point reduction in NAFLD Activity Score (NAS), and ≥2-point reduction in NAS without worsening of fibrosis. Denifanstat-treated patients also showed statistically significant fibrosis improvement with no worsening of NASH, and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo.
No treatment-related serious adverse events (SAEs) were observed, and the majority of adverse events (AEs) were mild to moderate in nature.
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of NASH, for which there are no treatments currently approved in the United States or Europe. FASCINATE-2, a Phase 2b clinical trial of denifanstat in NASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit www.sagimet.com.
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