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Terns Reports Positive Top-line Results from Phase 1 Proof of Concept Clinical Trial of THR-β agonist TERN-501
TERN-501 demonstrated significant effects on key pharmacodynamic marker of THR-β engagement linked to NASH histologic efficacy TERN-501 was generally safe and
About this update from Terns Pharmaceuticals, Inc.
[{"type":"text","content":"TERN-501 demonstrated significant effects on key pharmacodynamic marker of THR-β engagement linked to NASH histologic efficacy TERN-501 was generally safe and well-tolerated with predictable pharmacokinetic profile with low variability Terns plans to initiate first FXR/THR-β agonist combination trial in NASH in 1H 2022 FOSTER CITY, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported positive top-line results from a Phase 1 clinical trial of TERN-501, a thyroid hormone receptor beta (THR-β) agonist in development for the treatment of patients with NASH. The Phase 1 clinical trial includes single ascending dose (SAD), multiple ascending dose (MAD) and drug-drug interaction (DDI) cohorts evaluating the safety, tolerability, pharmacodynamics (PDs) and pharmacokinetics (PKs) of TERN-501. Healthy volunteers with mildly elevated low-density lipoprotein (LDL) cholesterol were randomized to placebo (n=2) or TERN-501 (n=6) in each cohort. Volunteers randomized to TERN-501 received single doses of 3, 10, 30 or 60 mg of TERN-501 in the SAD portion of the study or multiple doses of 3, 6 or 10 mg of TERN-501 once daily for 14 days in the MAD portion of the study. In the DDI portion of the study, volunteers received open label TERN-501 co-administered with TERN-101, the Company’s liver-distributed farnesoid X receptor (FXR) agonist also in development for the treatment of NASH. TERN-501 was generally safe and well-tolerated in the SAD and MAD cohorts with a similar incidence of adverse events (AEs) across all TERN-501 treatment groups and placebo. All AEs were mild to moderate with no apparent dose relationship. There were no treatment-emergent serious AEs (SAEs) and no volunteer discontinued TERN-501 or the study due to any AE. There were no cardiac safety signals, no incidence of diarrhea and no differences between TERN-501 dose groups and placebo in change from baseline in heart rate, blood pressure or other vital signs. Thyroid function test results were consistent with other THR-β agonists currently in clinical development, and there were no fi...