Policy & Regulation
Terns Pharmaceuticals Touts Positive Interim Results from Ongoing Phase 1 Clinical Trial of TERN-201, a SSAO Inhibitor in Development for NASH
14 August 2019 - - China- and US-based biopharmaceutical company Terns Pharmaceuticals, Inc has received interim results of an ongoing Phase 1 clinical trial of TERN-201, a semicarbazide-sensitive amine oxidase inhibitor, being developed for the treatment of NASH, the company said.

nterim data from the first-in-human clinical study of TERN-201 demonstrate that single, oral administrations of TERN-201 were well tolerated with no significant safety findings or adverse events observed that led to discontinuation.

Each dose level studied resulted in decreases from baseline in plasma SSAO activity that were maintained up to one week after single dose administrations of TERN-201.

Based on these results, the study has progressed to the multiple-dose phase.

The first-in-human trial of TERN-201 is a multiple phase, single- and multiple-ascending dose study in healthy human participants. In the first phase, study volunteers receive a single dose of TERN-201 or placebo in ascending dose cohorts.

In the second phase of the study, healthy participants receive repeat doses of TERN-201 or placebo, also in ascending dose cohorts.

The primary endpoint for each phase of the trial is safety and tolerability. Secondary endpoints include pharmacokinetics and pharmacodynamic biomarker assessments of SSAO target engagement.

TERN-201 was initially discovered and developed by Eli Lilly and company. Terns signed a global, exclusive agreement with Eli Lilly in 2018 to develop, manufacture, and commercialise TERN-201 for the treatment of NASH.

At The International Liver Congress 2019 in Vienna, Terns presented preclinical data demonstrating that TERN-201 improves the NAFLD Activity Score and fibrosis in rodent models of NASH.

Terns Pharmaceuticals is a clinical-stage pharmaceutical company that is focused on the discovery and development of medicines for chronic liver disease and cancer.

Based in China and the United States, the company is advancing a pipeline of drug candidates for the treatment of non-alcoholic steatohepatitis and cancer, across multiple modalities.

Terns leverages world class expertise in disease biology, medicinal chemistry, and clinical development in order to bring promising new therapies to patients in China and other global markets.