Policy & Regulation
Gannex Pharma doses first participant in DDI study of ASC42 to treat primary biliary cholangitis
16 August 2022 -

Gannex Pharma Co., Ltd., a company wholly-owned wholly owned by China-based Ascletis Pharma Inc. (HKEX: 1672), announced on Monday that it has completed the dosing of its first participant in the United States drug-drug interaction (DDI) study of Farnesoid X receptor (FXR) agonist ASC42 intended to treat primary biliary cholangitis (PBC).

The US-based study is likely to enrol 12 subjects in total this month and it will be completed by the beginning of the fourth quarter 2022.

ASC42is an in-house developed, novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property. An earlier Phase one clinical trial in the US showcased that the product is likely to be a potentially best-in-class PBC drug candidate as LDL-C levels were in normal range with no pruritus occurrence, and FXR target engagement biomarker FGF19 increased 1,780% when ASC42 was dosed at 15mg, once daily (QD) during the 14-day treatment.

The company is planning to start Phase III clinical trials in China, the US and the European Union after the completion of the ongoing Phase II clinical trial in China.

PBC is a chronic autoimmune cholestatic disease and frequently progresses to liver fibrosis and cirrhosis requiring liver transplantation or resulting in death.