{"id":27952,"date":"2025-02-25T17:25:09","date_gmt":"2025-02-25T09:25:09","guid":{"rendered":"https:\/\/flcube.com\/?p=27952"},"modified":"2025-02-25T17:25:11","modified_gmt":"2025-02-25T09:25:11","slug":"canbridge-pharmaceuticals-doses-first-patient-in-can108-biliary-atresia-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=27952","title":{"rendered":"CANbridge Pharmaceuticals Doses First Patient in CAN108 Biliary Atresia Study"},"content":{"rendered":"\n

China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228<\/a>) announced that the first patient has been dosed in the Phase II EMBARK study of CAN108 (maralixibat) for biliary atresia (BA). The global, multi-center, randomized, controlled trial aims to enroll 72 patients, including 20 in China, to evaluate the drug\u2019s efficacy and safety in post-operation BA patients.<\/p>\n\n\n\n

Drug Profile<\/strong>
Maralixibat, originally discovered by Mirum Pharmaceuticals, is an ileal bile acid transporter (IBAT) inhibitor that blocks bile acid enterohepatic circulation. The drug reduces liver and serum bile acid levels, alleviating liver injury and pruritus in patients with cholestatic liver diseases. Mirum received US FDA approval in September 2021 for maralixibat (trade name Livmarli) to treat cholestatic pruritus in Alagille syndrome (ALGS) patients aged \u22651 year. The drug is also in late-stage development for progressive familial intrahepatic cholestasis (PFIC) and BA, with breakthrough therapy (BTD) and orphan drug designations (ODD).<\/p>\n\n\n\n

CANbridge Partnership<\/strong>
In April 2021, CANbridge licensed exclusive rights from Mirum to develop and commercialize maralixibat in Greater China for ALGS, PFIC, and BA. The National Medical Products Administration (NMPA) accepted a New Drug Application (NDA) for ALGS in 2021 and granted priority review status.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based rare disease specialist CANbridge Pharmaceuticals Inc. 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