Terns Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing best-in-class single-agent and combination therapies to treat non-alcoholic steatohepatitis (NASH) and other liver diseases, announced today the presentation of new clinical data on an improved tablet formulation of its liver-distributed farnesoid X receptor (FXR) agonist TERN-101 at the Paris NASH Digital Experience, taking place virtually October 22-23, 2020. The presentation, entitled "Comparative pharmacokinetics of two oral formulations of nonsteroidal farnesoid X receptor agonist TERN-101 in healthy volunteers," demonstrated that an amorphous tablet formulation of TERN-101, which is currently being evaluated in the Phase 2a LIFT study in NASH patients, achieved faster absorption and higher plasma levels compared to a previous crystalline capsule formulation of TERN-101. The study results also demonstrate that the new formulation reduces pharmacokinetic variability and that TERN-101 can be administered without regard to food.
"In Terns’ Phase 1 studies, TERN-101 has demonstrated potent FXR activation in the liver and is well tolerated, with no observation of pruritus and no difference from placebo in serum lipid effects. We’ve now developed an improved formulation that optimizes absorption and minimizes PK variability," said Erin Quirk, M.D., President and Chief Medical Officer of Terns. "This new TERN-101 formulation is now being studied in our 12-week Phase 2a LIFT study in NASH patients, and we look forward to seeing the results in mid-2021."
Full details from the presentation can be found at www.ternspharma.com/scientific-publications.
About TERN-101 and Farnesoid X Receptor (FXR) Agonism
TERN-101 is a potent, non-steroidal FXR agonist, with enhanced liver distribution being developed for the treatment of NASH. FXR is a nuclear receptor that is highly expressed in the liver and small intestine. 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 NASH. TERN-101 has been granted Fast Track 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 it 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 biopharmaceutical company focused on developing best-in-class single-agent and combination therapies to treat non-alcoholic steatohepatitis (NASH) and other liver diseases. The company’s liver-selective FXR-agonist, TERN-101, is currently conducting a multi-center, randomized, double-blind, placebo-controlled Phase 2a clinical trial designed to evaluate efficacy, safety, and pharmacokinetics in 96 presumed NASH patients who receive placebo or TERN-101 at various dose levels for 12 weeks. Terns recently announced positive Phase 1 clinical data for its highly selective SSAO inhibitor, TERN-201, demonstrating potent and sustained target engagement. In addition, the company is actively planning to initiate clinical studies for its thyroid hormone receptor beta agonist TERN-501 as monotherapy and in combination with its other pipeline assets for NASH, as well as advancing its small molecule GLP-1R agonist program. Terns’ investors include OrbiMed, Vivo Capital, Lilly Asia Ventures, and Decheng Capital.
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