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    Home > Medical News > Medical Research Articles > Ganlai Announces First Patient Dosing in Phase II Clinical Trial of FXR Agonist ASC42 in Primary Biliary Cholangitis

    Ganlai Announces First Patient Dosing in Phase II Clinical Trial of FXR Agonist ASC42 in Primary Biliary Cholangitis

    • Last Update: 2022-05-24
    • Source: Internet
    • Author: User
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    -- Ganlai plans to initiate Phase III clinical trials in China, the United States and the European Union immediately after the completion of Phase II clinical trials in China .


    --The 2010 Chinese epidemiological study showed that the number of PBC patients in China was about 656,000 , of which 440,000 were female patients over the age of 40 .


    SHANGHAI , April 10, 2022 /PRNewswire/ -- Gan Lai Pharmaceuticals Co.


    This phase II clinical trial (clinical trial number: NCT05190523) consists of three ASC42 drug treatment groups (5 mg, 10 mg and 15 mg) and a placebo control group, and plans to enroll 100 patients with ursodeoxycholic acid ( UDCA) patients with poor response or intolerance, the enrollment ratio is 1:1:1:1, and the course of treatment is 12 weeks, which is expected to be completed by the end of 2022


    In November 2021, the China National Medical Products Administration ("NMPA") approved a Phase III clinical trial protocol for 210 PBC patients


    ASC42 is a novel and highly selective non-steroidal farnesoid X receptor (FXR) agonist, which is completely independently developed by the company, owns global intellectual property rights, and is expected to be the best-in-class


    Ursodeoxycholic acid (UDCA) is currently the only drug approved for the treatment of PBC in China, however, about 40% of PBC patients have poor response or intolerance to UDCA [1]


    A Chinese epidemiological study in 2010 showed that the number of PBC patients in China was about 656,000, of which 440,000 were female patients over the age of 40 [2]


    Dr.


    [1] Lindor KD, Bowlus CL, Boyer J, et al.


    About Song Li

    Ascletis is an innovative R&D-driven biotechnology company listed on the Hong Kong Stock Exchange (1672.


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