Terns Pharmaceuticals announced the U.S. FDA has granted Fast Track status to their investigational farnesoid X receptor (FXR) agonist, TERN-101, for the treatment of non-alcoholic steatohepatitis (NASH).
A completed phase 1 trial demonstrated clinical pharmacokinetic properties consistent with once-daily dosing. Terns presented preclinical data at the International Liver Congress 2019 in Vienna, demonstrating that TERN-101 reduced liver steatosis, inflammation, ballooning, and fibrosis in a preclinical model of non- alcoholic steatohepatitis (NASH).
Fast Track is a process designed to facilitate the expedited development and review of new drugs to treat serious or life-threatening conditions and which have demonstrated the potential to fill an unmet medical need. The purpose is to advance new drugs earlier for patients who need them.
Terns signed a global, exclusive license agreement with Eli Lilly in 2018 to develop, manufacture, and commercialize TERN-101.
About TERN-101 and Farnesoid X Receptor (FXR) Agonism
TERN-101 is a potent non-bile acid FXR agonist being developed as a therapeutic for NASH. FXR is a nuclear receptor that is highly expressed in the liver and small intestine. Bile acids (BA) are natural ligands of FXR, and their binding with and activation of FXR is critical to the regulation of cellular pathways that modulate BA synthesis, lipid metabolism, inflammation, and fibrosis. FXR agonism and activation have demonstrated improvement over placebo in regression of histological liver fibrosis without progression to NASH in a late-stage study, demonstrating the potential for FXR agonists to be a new treatment modality for NAFLD and NASH.
Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease (NAFLD), which is caused by the accumulation of excess fat in the liver. NASH is associated with chronic liver inflammation and liver cell injury, and it can lead to fibrosis, cirrhosis, and eventually liver cancer or liver failure. Global rates of NAFLD and NASH are increasing rapidly, in tandem with rising rates of obesity. There is currently no approved medication for the treatment of NASH.