Terns Pharmaceuticals to Present Data on Multiple NASH Programs at The Digital International Liver Congress™ 2020

Foster City, Calif., United States: 

-Single doses of TERN-201 were safe and well tolerated and demonstrated potent, selective, and sustained inhibition of SSAO in a Phase 1 clinical trial, with near complete inhibition of plasma SSAO activity observed-

-TERN-501 demonstrated potent and selective THR-β agonism, and significantly reduced liver steatosis, fibrosis, and serum markers of liver damage in NASH preclinical rodent models-

Terns Pharmaceuticals, Inc., a biopharmaceutical company focused on developing best-in-class, single-agent and combination therapies to treat liver disease, announced today three poster presentations on two lead programs at The Digital International Liver Congress™ 2020, taking place August 27-29, 2020. The presentations include clinical and preclinical data for TERN-201, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor, and in vivo rodent model data for TERN-501, a preclinical thyroid hormone receptor beta (THR-β) agonist, both for the treatment of non-alcoholic steatohepatitis (NASH).

“At the upcoming Digital International Liver Congress, we are excited to share data from multiple studies of our SSAO inhibitor, TERN-201, and the first data for TERN-501, our THR-β agonist, each important mechanisms of action within our Terns’ NASH combination strategy,” said Erin Quirk, M.D., President and Chief Medical Officer of Terns. “Clinical data for TERN-201 demonstrate that it has strong target engagement and is generally safe and well tolerated, and indicate that TERN-201 has the potential to impact inflammation and fibrosis in NASH. Both programs also demonstrated strong preclinical data. In rodent models of hypercholesterolemia and fibrotic NASH, TERN-501 rapidly lowered serum cholesterol, reversed liver steatosis and improved liver inflammation and fibrosis, indicating it has the potential to greatly benefit patients as a best-in-class THR-β agonist with potential for use both as a monotherapy, but perhaps more importantly, in combination with our other lead NASH candidates.”

Details of the presentations are as follows:

Presentation Title:Single doses of TERN-201, a novel selective semicarbazide-sensitive amine oxidase (SSAO) inhibitor, are safe, well-tolerated, and result in sustained reduction of SSAO activity in healthy participants
Presentation Number: FRI-088
Session: NAFLD: Therapy
Date: August 28, 2020
Presenter: Martijn Fenaux
Data Highlights:
All dose levels of TERN-201 were safe and well tolerated in healthy subjects with no clinically relevant adverse events reported when administered as a single oral dose ranging from 1 mg to 10 mg. Inhibition of plasma SSAO amine oxidase activity and dose-dependent increases in plasma methylamine (MMA) were sustained up to 1 week after single doses of TERN-201, suggesting potent, covalent target engagement and supporting once daily dosing despite a short plasma half-life.

Poster Title:Anti-inflammatory and anti-fibrotic activity of TERN-201, a semicarbazide-sensitive amine oxidase inhibitor, in a rat choline-deficient high-fat diet non-alcoholic steatohepatitis model
Presentation Number: SAT-032
Session: NAFLD: Experimental and Pathophysiology
Date: August 29, 2020
Presenter: Martijn Fenaux
Data Highlights:

• Dosing with TERN-201 resulted in significant reductions in liver inflammation (p<0.001) and gene expression associated with inflammation in a rat model of NASH.
• TERN-201 also reduced gene expression markers of fibrosis (p<0.005) and liver injury (p<0.05), supporting further development of this drug in patients with NASH.

Poster Title:TERN-501, a potent and selective agonist of thyroid hormone receptor beta, strongly reduces histological features and biomarkers of non-alcoholic steatohepatitis associated pathology in rodent models
Presentation Number: SAT-066
Session: NAFLD: Experimental and Pathophysiology
Date: August 29, 2020
Presenter: Martijn Fenaux
Data Highlights:

• TERN-501 exhibited potent and selective THR-β agonism (THR-β EC₅₀=100nM; THR-α EC₅₀=2,600nM) with good PK properties.
• In a rat hypercholesterolemic model, a robust and dose-dependent reduction in total cholesterol of up to 71% (p < 0.0001 vs. vehicle) was observed.
• In a mouse NASH model, TERN-501 reduced steatosis significantly when compared to control mice. Significant reductions in serum total cholesterol, triglyceride and ALT levels were also observed at all dose levels tested.
• TERN-501 also significantly modulated gene expression in multiple pro-fibrotic stellate cell pathways relevant to the progression of NASH.

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