Gannex Received U.S. IND Approval for Its NASH Drug Candidate ASC42,an FXR Agonist

Shanghai, China, 12 October 2020 -- Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) announces today that it received investigational new drug application (IND) approval from FDA for its drug candidate ASC42, to conduct clinical trials for non-alcoholic steatohepatitis (NASH) indication.

ASC42 is an in-house developed, novel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis. ASC42 is an oral tablet formulation developed with proprietary therapy and is stable at room temperature.

Gannex has two additional drug candidates at clinical stage in its NASH pipeline, ASC40 and ASC41. ASC40(TVB-2640), an oral fatty acid synthase (FASN) inhibitor, has been shown to significantly reduce liver fat with a 61% responder rate in the 50 mg group in Phase II clinical trial (FASCINATE-1). ASC41 is a liver-targeted prodrug and its active moiety (ASC41-A) is selective for THR-β. ASC42 is expected to be used alone or in combination with ASC40 or ASC41.

“We are delighted that the FDA has cleared ASC42 IND for NASH, an increasingly prevalent disease for which there are currently no approved therapies,” said Dr. Handan He, Chief Scientific Officer of Ascletis, “This is an important milestone that allows us to commence our clinical trials this year. We will continue our commitment to patient-centric innovation and develop new medicines to address the unmet needs in NASH treatment.”

About NASH

NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver, inflammation and fibrosis (scarring), and can eventually lead to cirrhosis and liver failure. NASH is a major cause of liver disease worldwide and the leading cause of liver transplants for people under 50 in the US. There are currently no approved treatments for NASH.