Sagimet Biosciences Reports Finalized Phase 1 Study on Denifanstat for Liver Dysfunction

Sagimet Biosciences, a biopharmaceutical firm listed on Nasdaq (SGMT), has successfully concluded a Phase 1 study on denifanstat, a drug candidate aimed at treating metabolic dysfunction-associated steatohepatitis (MASH). The research, which is part of the drug's development for MASH, evaluated the safety and pharmacokinetics in subjects with varying degrees of liver impairment. The non-randomized study involved 38 participants, including those with mild, moderate, and severe liver impairment, as well as a control group of 14 healthy individuals. Each participant received a daily oral dose of 50 mg denifanstat for four days. The drug was found to be well-tolerated with no reported safety issues, and the pharmacokinetic data is expected to aid in the planning of a Phase 3 trial.
Sagimet specializes in developing FASN inhibitors to address diseases linked to the overproduction of palmitate, a fatty acid. Their lead product, denifanstat, is an oral medication being developed to treat MASH. A prior Phase 2b clinical trial, FASCINATE-2, demonstrated positive outcomes for denifanstat in treating MASH.
MASH is a serious liver condition affecting over 115 million people globally. In 2023, medical societies and patient groups renamed NAFLD to MASLD and NASH to MASH to provide a non-stigmatizing term. An umbrella term, SLD, was also introduced to cover various liver diseases related to fat accumulation.

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