Business
Terns Announces Initiation of Patient Dosing in AVIATION Phase 1b NASH Clinical Trial of VAP-1 Inhibitor TERN-201
TERN-201 is a highly selective VAP-1 inhibitor intended to address chronic liver inflammation and fibrosis in NASH Sustained VAP-1 inhibition with TERN-201
About this update from Terns Pharmaceuticals, Inc.
[{"type":"text","content":"TERN-201 is a highly selective VAP-1 inhibitor intended to address chronic liver inflammation and fibrosis in NASH Sustained VAP-1 inhibition with TERN-201 may make it suitable for co-administration with other Terns therapiesTopline TERN-201 NASH clinical data expected in first half of 2022 FOSTER CITY, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced the initiation of patient dosing in the AVIATION Trial, a Phase 1b clinical trial evaluating TERN-201, an orally-administered, highly selective inhibitor of vascular adhesion protein-1 (VAP-1) in patients with NASH. The AVIATION Trial (NCT04897594) is a multi-center, randomized, double-blind, dose-ranging, placebo-controlled, proof of concept, adaptive, Phase 1b clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of TERN-201 in patients with presumed non-cirrhotic NASH and a cT1 value of greater than 800ms. Corrected T1, or cT1, is a magnetic resonance-based imaging test measuring liver inflammation and fibrosis that has been associated with clinical outcomes and liver histology. The primary objective of the AVIATION Trial is to evaluate the safety and tolerability of TERN-201 versus placebo when given for 12 weeks in patients with NASH. The clinical trial will be conducted in two parts: Part 1 of the trial has begun with a dose of 10 mg as compared to placebo while Part 2 is expected to enroll additional dose cohorts of TERN-201 based on an interim assessment of the 10 mg cohort. Each part of the AVIATION Trial is planned to include approximately 20 patients receiving each of the designated doses of TERN-201 and approximately 10 patients receiving placebo. The clinical trial will also explore the effects of TERN-201 on NASH imaging biomarkers (such as cT1) and NASH blood biomarkers (such as CK-18). Preliminary topline 12-week data from Part 1 and Part 2 of the AVIATION Trial are expected in 1H 2022 and 2H 2022, respectively. “Increasing evidence points to the role of VAP-1 in recruiting white blood cells to the liver as a key factor driving liver ...