Hepagene Therapeutics, Inc. a China-based clinical-stage biopharmaceutical company, announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HPG7233, an agonist of Thyroid Hormone Receptor beta (THR-Beta) intended for the treatment of patients with non-alcoholic steatohepatitis (NASH) and dyslipidaemia.

HPG7233 is a highly selective small molecule THR-Beta agonist with liver enrichment profile. It demonstrated high selectivity and potency in preclinical studies and a significant reduction in liver triglyceride and serum LDL-C in the relevant animal models in preclinical studies. The company said that the study has seen remarkable synergistic effect in the combination groups, especially in combination with HPG1860 (Hepagene's internal Phase II FXR agonist).

Michael X. Xu, PhD, Hepagene president and CEO, said, 'We are delighted that FDA has cleared the IND application for HPG7233, which expands our NASH pipeline and represents another important milestone for Hepagene. We plan to initiate HPG7233 clinical study soon and look forward to implementation of this project successfully. To improve the modest efficacy observed with first generation of NASH candidates, we will also actively explore combo studies of THR-? agonist with internal FXR and/or GLP-1R agonist.'