Terns Pharmaceuticals announced the initiation of a Phase 1 clinical trial of TERN-101, a farnesoid X receptor (FXR) agonist, being developed for the treatment of non-alcoholic steatohepatitis (NASH). Initiation of the study in the US follows US Food and Drug Administration (FDA) clearance of the Investigational New Drug application for TERN-101 filed earlier this year.
“We’ve made significant progress this year, advancing the development of our lead program, TERN-101, as part of our dedicated approach to NASH, a condition with no existing treatment options,” said Erin Quirk, M.D., Chief Medical Officer of Terns. “We look forward to evaluating data from this trial later this year as we assess the potential benefits of TERN-101 in the treatment of NASH.”
The Phase 1 trial of TERN-101 is a randomized, double-blind, placebo-controlled study designed to evaluate safety, pharmacokinetics, and plasma biomarkers of FXR pathway activation in participants receiving placebo or TERN-101 at various dose levels for 7 days.
Initially discovered and developed by Eli Lilly and Company, TERN-101 was previously advanced through a Phase 1 study and demonstrated clinical pharmacokinetic properties consistent with once daily dosing. In 2018, Terns announced a global, exclusive agreement with Eli Lilly to develop, manufacture, and commercialize TERN-101 for the treatment of NASH. Terns previously presented preclinical data at The International Liver Congress™ 2019 in Vienna demonstrating that TERN-101 reduces liver steatosis, inflammation, ballooning, and fibrosis in a diet-induced obese mouse model of NASH. In addition to the Phase 1 trial now ongoing in the US, Terns also plans studies in China as part of the TERN-101 development plan.