KUALA LUMPUR, June 13 (Bernama) -- Terns Pharmaceuticals Inc, a clinical-stage pharmaceutical company has announced the initiation of a Phase 1 clinical trial of TERN-101, a farnesoid X receptor (FXR) agonist, developed for the treatment of non-alcoholic steatohepatitis (NASH).
The Phase 1 trial of TERN-101 is a randomised, double-blind, placebo-controlled study designed to evaluate the safety, pharmacokinetics and plasma biomarkers of FXR pathway activation in participants receiving placebo or TERN-101 at various dose levels for seven days.
According to a statement, the initiation of the study in the United States (US) follows US Food and Drug Administration clearance of the Investigational New Drug application for TERN-101 filed earlier this year.
“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,” said Terns chief medical officer, Erin Quirk, M.D.
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.
Last year, Terns announced a global, exclusive agreement with Eli Lilly to develop, manufacture and commercialise TERN-101 for the treatment of NASH. The company also plans studies in China as part of the TERN-101 development plan.
For more information, contact https://www.ternspharma.com.
-- BERNAMA
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