-LIFT study to assess safety and efficacy of farnesoid X receptor (FXR) agonist TERN-101 in fatty liver disease patients as an important first step toward combination NASH studies-
Terns Pharmaceuticals, Inc., a global biopharmaceutical company focused on discovering and developing innovative therapies to treat liver disease and cancer, today announced that it has screened the first patient for the LIFT study, a Phase 2a clinical trial of TERN-101, a liver-selective farnesoid X receptor (FXR) agonist, the company's lead development candidate for the treatment of non-alcoholic steatohepatitis (NASH).
"Initiating the LIFT study in NASH patients is an exciting milestone for Terns and an important next step in advancing TERN-101 as the backbone for future combination treatment for NASH," said Erin Quirk, M.D., Chief Medical Officer of Terns. "We are building upon the positive Phase 1 study results which demonstrated that TERN-101 potently suppresses 7α-C4, a liver FXR activation biomarker, and has a favorable safety profile. We look forward to assessing the safety and efficacy of TERN-101 monotherapy in NASH through the LIFT study and, subsequently, exploring combinations of TERN-101 with Terns’ THR-β agonist, TERN-501."
The LIFT study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a clinical trial designed to evaluate efficacy, safety, and pharmacokinetics in 96 NASH patients who receive placebo or TERN-101 at various dose levels for 12 weeks. The primary objective for the trial is assessing safety, with a secondary objective of assessing change in alanine aminotransferase levels with TERN-101. The study will also evaluate standardized biomarkers of tissue fat concentration (MRI-derived proton density fat fraction) and NASH-associated fibrosis.
"The LIFT study underscores Terns’ commitment to bring forward best-in-class combinations to NASH patients who are in great need of new treatment approaches," said Weidong Zhong, CEO and President of Terns. "We have recently seen significant progress in ongoing NASH trials, but there remains a need for well-tolerated, convenient therapies with much higher response rates. Many experts believe that combination therapy will be needed to achieve better outcomes for patients. With initiation of the LIFT study, we are one step closer to evaluating just such a combination: our potent and well-tolerated FXR agonist, TERN-101, with our potentially best-in-class THR-β agonist, TERN-501, which is scheduled to enter development later this year."
TERN-101 Phase 1 Clinical Trial Results Summary
Four Phase 1 studies of TERN-101 have been completed. Oral dose administration of TERN-101 resulted in 74% to 91% dose-dependent reductions in 7α-C4, a fluid biomarker whose production is inhibited by FXR activation in the liver. FGF19, a biomarker of intestinal FXR agonism, increased between 6- to 8-fold from baseline after TERN-101 dosing. TERN-101 was well tolerated in each of the studies. No subjects who were dosed with TERN-101 reported pruritus in any of these initial Phase 1 trials.
About TERN-101 and Farnesoid X Receptor (FXR) Agonism
TERN-101 is a potent, liver-selective, non-bile acid FXR agonist being developed for the treatment of NASH. FXR is a nuclear receptor that is highly expressed in the liver and small intestine. Bile acids (BA) are natural ligands of FXR, and their binding with and activation of FXR is critical to the regulation of cellular pathways that modulate BA synthesis, lipid metabolism, inflammation, and fibrosis. FXR agonism has demonstrated improvement over placebo in regression of histological liver fibrosis without progression of NASH in a late-stage study, demonstrating the potential for FXR agonists to be a new treatment modality for non-alcoholic steatohepatitis (NASH). TERN-101 has been granted FastTrack Designation by the U.S. Food and Drug Administration (FDA) for the treatment of NASH.
Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease (NAFLD), which is caused by the accumulation of excess fat in the liver. NASH is associated with chronic liver inflammation and liver cell injury, and can lead to fibrosis, cirrhosis, and eventually liver cancer or liver failure. Global rates of NAFLD and NASH are increasing rapidly, in tandem with rising rates of obesity. There is currently no approved medication for the treatment of NASH.
About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. 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 NASH, primary biliary cholangitis, 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.
For more information, visit www.ternspharma.com and www.ternspharma.com.cn
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