Hepagene Therapeutics Announces FDA Clearance of Investigational New Drug Application (IND) for HPG7233 THR Beta Agonist

HONG KONG and NANJING,China,Sept. 20,2023 -- Hepagene Therapeutics,Inc. a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its HPG7233,an agonist of Thyroid Hormone Receptor beta (THR-β) for the treatment of patients with non-alcoholic steatohepatitis (NASH) and dyslipidemia.

HPG7233 is a highly selective small molecule thyroid hormone receptor beta (THR-β) agonist with liver enrichment profile. In preclinical studies,HPG7233 demonstrated high selectivity and potency,significant reduction of liver triglyceride and serum LDL-C in the relevant animal models. More importantly,remarkable synergistic effect has been observed in the combination groups,especially in combination with HPG1860 (Hepagene's internal Phase II FXR agonist). HPG7233 has excellent target tissue selectivity and has shown good safety and tolerability in the toxicology studies with no adverse findings related to THR-α subtypes or in gastrointestinal tract. These results provide strong evidence to support continuing efforts in HPG7233 clinical development.

"We are delighted that FDA has cleared the IND application for HPG7233,which expands our NASH pipeline and represents another important milestone for Hepagene." said Michael X. Xu,PhD,President and CEO of 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-β agonist with internal FXR and/or GLP-1R agonist." Based on its superior preclinical profile,HPG7233 has great potential to become the next generation of THR-β agonist to benefit patients with NASH and dyslipidemia.

About HPG7233

THR-β isoform is mainly expressed in the liver. The activation of THR-β is beneficial to the reduction of liver fat and the improvement of dyslipidemia. HPG7233 is a novel liver-targeted and highly selective small molecule thyroid hormone receptor beta (THR-β) agonist aimed at serum and liver lipid metabolism. HPG7233 demonstrates high selectivity and potency,great liver-enrichment and liver/plasma exposure profile in rodent and non-rodent animals,significant reduction of liver triglyceride and serum LDL-C and significant reduction of NAS score in NASH model.

About Hepagene Therapeutics,Inc.

Hepagene Therapeutics,Inc. a clinical-stage biopharmaceutical company,devotes its drug discovery and development efforts towards discovering,developing and delivering innovative medicines that help patients prevail over liver diseases and other life-threatening diseases,especially non-alcoholic steatohepatitis (NASH),chronic Hepatitis B infection (HBV),liver cancer or advanced solid tumors.

For further information,please contact:

Ms. Tao

Investor@hepagene.com