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Gannex Announces First Subject Dosed in the U S Drug-Drug Interaction Study of FXR Agonist ASC42 for Treatment of Primary Biliary Cholangitis - Press Release

Gannex Announces First Subject Dosed in the U S Drug-Drug Interaction Study of FXR Agonist ASC42 for Treatment of Primary Biliary Cholangitis

Gannex Announces U S FDA Clearance of Clinical Trial on FXR Agonist ASC42 for Treatment of Primary Biliary Cholangitis

ASC42 has completed Phase I trials in the U.S. and China. This approval from U.S. FDA enables Gannex to complete a critical drug-drug interaction (DDI) study to support upcoming Phase III trials in China, the U.S. and European Union Gannex expects to complete this DDI study at the beginning of Q4, 2022 Currently, Phase II clinical trial of FXR agonist ASC 42 in China is in progress. Gannex intends to start Phase III clinical trials in China, the U.S. and European Union after the completion of the Phase II clinical trial which is ongoing in China SHANGHAI, June 8, 2022 /PRNewswire/ Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672) today announces that it has obtained the U.S. FDA clearance for itsdrug candidate, ASC42, to initiate a drug-drug interaction (DDI) study. This important DDI study is designed to provide more evidence to support upcoming Phase III clinical trials in China, the U.S. and European Union for treatment of primary biliary cholangitis (PBC).

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