CANbridge Pharmaceuticals has dosed the first patient in the phase 2 EMBARK study of CAN108 (maralixibat) in biliary atresia (BA) in China.

The clinical trial in China is part of the larger EMBARK clinical trial in biliary atresia, which is being carried out at various sites in North America, Asia, and Europe.

The multi-center randomized controlled mid-stage trial will assess the efficacy and safety of CAN108 in biliary atresia patients who had Kasai surgery.

CANbridge Pharmaceuticals expects to enroll up to 20 patients in the EMBARK clinical trial in China. Overall, the mid-stage trial will globally feature 72 patients.

James Xue — CANbridge Pharmaceuticals Founder, Chairman, and CEO said: “We are delighted to have dosed the first patient in our CAN108 trial in biliary atresia at Beijing’s prestigious Children’s Hospital of Capital Institute of Pediatrics.

“With the approval of CAN108 for the treatment of Alagille syndrome under the Early and Pilot Implementation Policy in Boao Lecheng International Medical Tourism Pilot Zone, we are advancing the study of CAN108 in two indications in China, where we hope to bring new treatment options for rare liver disease patients.”

Maralixibat under the brand is an orally administered, daily once, ileal bile acid transporter (IBAT) inhibitor, which has approval from the US Food and Drug Administration for treating cholestatic pruritus in Alagille syndrome (ALGS) patients, aged one year and older.

CANbridge Pharmaceuticals has an exclusive license agreement with Mirum Pharmaceuticals for developing, commercializing, and manufacturing, under certain conditions, of maralixibat (CAN108) in Greater China.

As per the terms of the agreement, CANbridge Pharmaceuticals holds the right to develop and commercialize the drug for three indications in Greater China that include Alagille syndrome, biliary atresia, and progressive familial intrahepatic cholestasis.

  biliary atresia, CAN108, CANbridge Pharmaceuticals, China, EMBARK trial, James Xue, Maralixibat, Mirum Pharmaceuticals