Terns Pharmaceuticals to Present Positive Data on Single-Agent and Combination NASH Programs at The Liver Meeting® Digital Experience 2020
FOSTER CITY, Ca. October 14, 2020 ?Terns Pharmaceuticals, Inc., a biopharmaceutical company focused on developing best-in-class, single-agent and combination therapies to treat liver disease, announced today that four abstracts detailing both clinical and preclinical data for multiple non-alcoholic steatohepatitis (NASH) programs within the company's portfolio were accepted for presentation at The Liver Meetingtm Digital Experience 2020, taking place November 13-16, 2020. The abstracts were published in the October supplement of Hepatology, the peer-reviewed journal of AASLD.
"At the upcoming Annual AASLD meeting, we will present data from across our diverse, best-in-class NASH pipeline, including the first preclinical evidence we have seen supporting the rationale for combining TERN-101, our farnesoid X receptor (FXR) agonist currently in Phase 2 studies, and TERN-501, our thyroid hormone receptor (THR) beta agonist," said Erin Quirk, M.D., President and Chief Medical Officer of Terns. "The early data we are seeing across our programs is very promising. We look forward to continuing our momentum into next year, when we anticipate having results from several clinical studies within our NASH development programs, including the Phase 2a LIFT study of TERN-101 in NASH patients, the TERN-501 first-in-human Phase 1 monotherapy results, and a Phase 1 study of TERN-101 co-administered with TERN-501."
Presentation details:
Poster Title: Combination of TERN-101, a farnesoid X receptor agonist, and TERN-501, a selective agonist of thyroid hormone receptor beta, reduces activation of inflammatory and fibrotic gene pathways in a mouse model of non-alcoholic steatohepatitis
Presentation Number: 517
Session: Experimental NAFLD and NASH
Presenter: Christopher Jones
Poster Title: Multiple ascending doses of TERN-201, a novel selective semicarbazide-sensitive amine oxidase (SSAO) inhibitor, fully suppresses plasma SSAO activity in a Phase 1 study
Presentation Number: 1683
Session: NAFLD and NASH: Therapeutics - Pharmacologic and Other
Presenter: Christopher Jones
Poster Title: TERN-101, a liver selective FXR agonist, is well-tolerated, and produces potent 7?-C4 reductions and FGF19 increases with no pruritis in healthy participants
Presentation Number: 1702
Session: NAFLD and NASH: Therapeutics - Pharmacologic and Other
Presenter: Martijn Fenaux
Poster Title: Pharmacokinetics and Tissue Distribution of TERN-201, a Novel Investigational SSAO/VAP-1 Inhibitor, in Preclinical Species
Presentation Number: 569
Session: Experimental NAFLD and NASH
Presenter: Martijn Fenaux
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.
About TERN-201 and Semicarbazide-Sensitive Amine Oxidase (SSAO) Inhibition
SSAO, also known as VAP-1 (Vascular Adhesion Protein-1), is a cellular adhesion protein with amine oxidase activity that contributes to NASH by increasing oxidative stress through the generation of H2O2 and recruitment of white blood cells into the liver, leading to inflammation and hepatic fibrosis. SSAO is upregulated in the vasculature of inflamed tissues, and soluble SSAO is elevated in patients with NASH. Inhibition of SSAO may provide a therapeutic benefit for patients with NASH and other chronic fibrotic liver diseases by reducing oxidative stress and the recruitment of inflammatory cells into the liver. TERN-201 is a potent and highly specific SSAO inhibitor with >7,000-fold in vitro selectivity for SSAO over off-target monoamine oxidases (MAO). Certain MAOs could be associated with potential drug-drug interactions in the NASH patient population. TERN-201 has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of NASH.
About TERN-501 and Thyroid Hormone Receptor Beta (THR-?)
THR-? is a nuclear hormone receptor that is highly expressed in the liver and plays a central role in lipid metabolism, regulation of blood cholesterol and triglyceride levels, and prevention of steatosis (excess fat buildup in the liver). Steatosis is a key driver of NASH, a serious and progressive liver disease characterized by liver inflammation known as steatohepatitis. Small molecule agonists of THR-? represent a promising class of NASH therapies because of their ability to increase metabolism, normalize blood lipid parameters, and reduce steatosis. Terns is pursuing a novel therapeutic approach to selectively activate THR-? in the liver, thereby avoiding potential off-target effects in other tissues. TERN-501 is a highly potent and selective small molecule THR- ? agonist.
About 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 liver disease including a pipeline of orally administered drug candidates for the treatment of 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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