Biopharmaceutical company Terns Pharmaceuticals Inc stated on Tuesday that its investigational farnesoid X receptor (FXR) agonist TERN-101 has passed US Food and Drug Administration (FDA) Fast Track Designation for the treatment of NASH.

NASH is a severe form of non-alcoholic fatty liver disease (NAFLD), which is caused by the accumulation of excess fat in the liver.

At The International Liver Congress 2019 in Vienna, the company reportedly presented the preclinical data demonstrating that TERN-101 reduced liver steatosis, inflammation, ballooning and fibrosis in a preclinical model of NASH.

Under the company's Phase 1 studies, TERN-101 demonstrated clinical pharmacokinetic properties consistent with once-daily dosing.

Both TERN-101 and TERN-201 are being developed for the treatment of NASH. ITERN-101 is a potent non-bile acid FXR agonist being developed as a therapeutic for NASH. 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, concluded the company.