Sagimet Biosciences Inc. is advancing its drug development pipeline with denifanstat, a fatty acid synthase (FASN) inhibitor, poised to enter two pivotal Phase 3 trials (FASCINATE-3 and FASCINIT) by the end of 2024 for the treatment of non-cirrhotic MASH (Metabolic dysfunction-associated steatohepatitis) with moderate to advanced liver fibrosis. This progress follows successful End-of-Phase 2 meetings and the acquisition of breakthrough therapy designation for denifanstat, signaling significant regulatory support.
The Phase 3 trials aim to evaluate the efficacy and safety of denifanstat in patients with MASH, a severe form of nonalcoholic fatty liver disease (NAFLD). MASH is characterized by liver inflammation and damage, which can lead to cirrhosis, liver failure, and hepatocellular carcinoma. Currently, there are limited approved treatments for MASH, highlighting the unmet medical need and the potential impact of denifanstat.
Sagimet's financial position is robust, with $170 million in cash reserves reported at the end of the third quarter of 2024. This financial stability is projected to sustain operational expenditures through 2025, providing a solid foundation for ongoing clinical trials and research activities. The company's strategic partnerships, including the completion of enrollment in a Phase 3 acne trial by partner Ascetis, further bolster its growth prospects.
Analyst Ratings
TD Cowen analyst Ritu Baral initiated a Buy rating for Sagimet, citing the company's strategic advancements in drug development and promising clinical trial outcomes. UBS also initiated coverage with a Buy rating on the stock with a $12.00 price target. These positive ratings reflect confidence in Sagimet's potential for value creation and growth.
Denifanstat: A FASN Inhibitor
Denifanstat is designed to inhibit fatty acid synthase (FASN), an enzyme crucial for de novo lipogenesis. By inhibiting FASN, denifanstat aims to reduce the synthesis of fatty acids in the liver, thereby addressing the underlying metabolic dysfunction in MASH. The drug is administered orally.
Company Overview
Sagimet Biosciences Inc. (formerly 3-V Biosciences) is a clinical-stage biopharmaceutical company focused on developing therapeutics for diseases resulting from dysfunctional lipid metabolism pathways. In addition to denifanstat, Sagimet is developing TVB-3567, another FASN inhibitor, for the treatment of various types of cancers. The company is headquartered in San Mateo, California.
