Hepagene Therapeutics Receives FDA Clearance for HPG7233 THR Beta Agonist IND Application
Thursday, September 21, 2023
Hepagene Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for HPG7233, a Thyroid Hormone Receptor beta (THR-β) agonist designed to address the pressing needs of patients suffering from non-alcoholic steatohepatitis (NASH) and dyslipidemia.
HPG7233 represents a remarkable advancement in therapeutic innovation. It stands out as a liver-targeted, highly selective small molecule thyroid hormone receptor beta (THR-β) agonist that targets serum and liver lipid metabolism with exceptional precision.
Furthermore, HPG7233 has demonstrated excellent selectivity for target tissues, offering an added layer of safety and specificity. Toxicology studies have provided results, with no adverse findings related to THR-α subtypes or gastrointestinal tract issues, confirming its suitability for clinical development.
The preclinical studies have demonstrated its exceptional selectivity, potency, and its ability to greatly enrich the liver while maintaining an optimal liver/plasma exposure profile in both rodent and non-rodent animal models. Moreover, HPG7233 has consistently shown its ability to significantly reduce liver triglyceride levels, lower serum LDL-C (Low-Density Lipoprotein Cholesterol), and effectively reduce the NAS (NAFLD Activity Score) in NASH animal models.
Based on its preclinical profile, HPG7233 holds the promise of becoming the next generation THR-β agonist, offering new hope and potential for patients grappling with NASH and dyslipidemia.
