The Food and Drug Administration (FDA) has granted Fast Track designation to TERN-101 (Terns Pharmaceuticals) for the treatment of non-alcoholic steatohepatitis (NASH).

NASH is caused by the accumulation of excess fat in the liver. It is associated with liver inflammation and cell damage that can potentially lead to fibrosis, cirrhosis, and eventually liver cancer or liver failure. TERN-101 is a potent, non-bile acid farnesoid X receptor (FXR) agonist. FXR activation has been shown to prevent the progression from histological liver fibrosis to NASH. 

The designation was based on data from a preclinical study of TERN-101 in murine models with NASH that was presented at The International Liver Congress 2019 in Vienna. The administration of TERN-101 led to a dose-dependent increase in FXR-mediated gene expression, resulting in a reduction in liver steatosis, hepatocellular ballooning, inflammation, and triglycerides.

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“Receiving Fast Track designation for TERN-101 is an important step in bringing this promising treatment to patients as soon as possible, and we look forward to working with the agency as we advance TERN-101 through clinical development,” said Erin Quirk, MD, Chief Medical Officer of Terns. “We are pleased that the US FDA recognizes the potential for TERN-101 to address the unmet treatment need for patients with NASH, who currently have no therapeutic options.”

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