Hepagene Therapeutics, Inc, Announces Dosing of First Healthy Subject in a Phase I Study of HPG1860 for NASH

Hepagene Therapeutics, Inc, a clinical stage drug discovery and development company which devotes its efforts towards discovering, developing and delivering innovative medicines that help patients prevail over liver diseases, announced that it has dosed the first healthy volunteer in a phase I clinical trial of HPG1860 in the United States. HPG1860 is a non-bile acid, potent, selective and full farnesoid X receptor (FXR) agonist.

Hepagene's Phase I study of HPG1860, entitled "A Randomized, Double-Blind, Placebo Controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HPG1860", is to assess the safety, tolerability and pharmacokinetics and pharmacodynamics in single- and multiple-ascending dosed healthy volunteers. The study will also evaluate the food effect of HPG1860 in healthy subjects.

"HPG1860 is a non-bile acid FXR agonist and exhibits excellent differentiation profiles based on our preclinical research study," stated Dr. Michael X. Xu, Hepagene's CEO. "The primary goal of HPG1860 Phase I study is to understand the drug safety profile. At the same time, the results from PD biomarker study will help to establish a safe and efficacious dose for Phase II study. PBC/PSC indication will also be considered for HPG1860."

About HPG1860

HPG1860 is an investigational potent and selective full FXR agonist with a non-bile acid scaffold and is currently in first-in-human clinical phase I study. Through regulation of gene expression of bile acids, FXR serves as a key controller of bile acid homeostasis. FXR has been studied for its role in modulating inflammation and the expression of FXR is down-regulated during NASH development. HPG1860 exhibited superb efficacy and safety profile in preclinical research.

About NASH

Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common liver disease worldwide, with an approximate prevalence of 20-30% in western countries. An estimated 20-25% of these patients will further progress to NASH, marked by steatohepatitis, ballooning and inflammation. Typically, NASH is accompanied with liver fibrosis that can progress to liver cirrhosis and hepatocellular carcinoma. NASH is currently ranked the second most common reason for liver transplants in USA and is expected to become the leading cause for liver transplant by 2020.

About Hepagene Therapeutics, Inc.

Hepagene Therapeutics, Inc. devotes its drug discovery and development efforts towards discovering, developing and delivering innovative medicines that help patients prevail over liver diseases, especially non-alcoholic steatohepatitis (NASH), chronic Hepatitis B infection and liver cancer.

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