14 June 2019 | News
Trial to evaluate the safety and tolerability of the Farnesoid X Receptor (FXR) agonist TERN-101 to support its clinical trials for the treatment of nonalcoholic steatohepatitis (NASH)
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Terns Pharmaceuticals, Inc. and Shanghai Tuo Zhen Biological Technology Co., Ltd., on 13 June 2019, announced the launch of a clinical FXR agonist of TERN-101 Phase I trials to further support the clinical study of TERN-101 for the treatment of NASH. The clinical trial was initiated after the company received approval from the US Food and Drug Administration (US FDA) for the clinical trial review (IND) of TERN-101 new drug submitted by Takuya earlier this year.
Dr Erin Quirk, Chief Medical Officer of Takuya Bio, said: "This year Takuno has made significant progress in research and development projects for non-alcoholic steatohepatitis, including the further promotion of clinical research on TERN-101. NASH is a no-effective treatment. Means of illness. We look forward to receiving clinical data from this study later this year to further evaluate the potential benefits of TERN-101 in the treatment of NASH."
This clinical phase I trial is a randomized, double-blind, placebo-controlled, 7-day dosing study designed to assess the safety, pharmacokinetics, and farnesol X receptors of subjects at different drug doses ( FXR) The level of initiation of biomarkers in plasma.
Originally discovered and developed by Eli Lilly and Company, TERN-101 was found to have clinical pharmacokinetic properties consistent with once-daily dosing in previous European clinical studies. In 2018, Takuya Bio and Lilly signed a cooperation agreement to acquire the global development, production and commercialization rights of TERN-101 for the treatment of NASH. Takuya Biotech published preclinical data at the EASL International Liver Diseases Annual Meeting in Vienna in April 2019, demonstrating that TERN-101 reduces hepatic steatosis, inflammation, and liver fibrosis in a diet-induced obese mouse NASH model. In addition to the ongoing clinical trials in the United States, Takuya Biotech plans to conduct clinical research in China as part of the TERN-101 global R&D program.