Shanghai/August.1st, 2022 — Eccogene announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to commence Phase I trial of its thyroid hormone receptor agonist ECC4703 in U.S. This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC4703 in healthy participants and subjects with elevated LDL.
Thyroid hormone receptor (THR) is a type of nuclear receptor that is activated by thyroid hormone. THRβ in the liver is responsible for the benefits of liver fat reduction and atherogenic lipid lowering. Clinical experiences of other THRβ agonists, e.g. MGL-3196 and VK2809, strongly suggested THR’s therapeutic potential for the treatment of non-alcoholic steatohepatitis (NASH) and dyslipidemia.
NASH is a metabolic liver disease potentially leading to fatal hepatic failure and cardiovascular outcomes. Dyslipidemia, including hypercholesterolemia or hypertriglyceridemia, is a lipid metabolic disorder and inadequate treatment of dyslipidemia may lead to serious cardiovascular events. The prevalence of NASH and dyslipidemia is parallel with the dramatic rise in the population of obesity and metabolic syndrome globally. No pharmacological treatments for NASH have been approved in major markets yet, while available drugs for treating dyslipidemia have the limitation of incomplete elimination of cardiovascular risks. THRβ agonism is currently one of the most appealing mechanisms as an oral therapy for NASH and dyslipidemia.
ECC4703 was discovered from Eccogene’s internal drug discovery platform. It is a β-selective, liver targeting THR full agonist. ECC4703 has demonstrated superiority in pre-clinical studies over partial agonist MGL-3196. It has also shown robust efficacy in pre-clinical models of NASH and dyslipidemia. “We will efficiently advance the clinical study of ECC4703 to provide a next generation THRβ agonist for the treatment of NASH and dyslipidemia.” said Dr. Jingye Zhou, CEO of Eccogene.
Eccogene is a clinical stage biopharmaceutical company dedicated to provide innovative therapeutic solutions to address unmet medical needs globally. The company focuses on discovery and development of translational medicine for metabolic and immune-related diseases.