Terns Pharmaceuticals initiates Ph1 clinical trial of TERN 101
Phase 1 study will evaluate the safety and tolerability of TERN-101, an FXR agonist in development for the treatment of NASH.
Terns Pharmaceuticals has announced the initiation of 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.