CANbridge Pharmaceuticals has dosed the first subject in the Phase II EMBARK clinical trial of CAN108 (maralixibat) in biliary atresia (BA) in China.

The first patient was dosed at Children’s Hospital of Capital Institute of Pediatrics (CIP) in Peking. 

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Sponsored by Mirum Pharmaceuticals, EMBARK is an international Phase II trial to analyse the safety and efficacy of CAN108 to treat BA patients following Kasai surgery.

This randomised, controlled trial for 26 weeks is being carried out at various sites in North America, Europe and Asia, including China. It will be followed by an open-label extension study for 78 weeks.

It is anticipated to enrol up to 20 subjects in China and 72 patients across the globe.

CANbridge and Mirum have an exclusive licence agreement to develop market and produce CAN108 under specific conditions in Greater China. 

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As per this deal, CANbridge holds the right for developing and marketing CAN108 for Alagille syndrome, progressive familial intrahepatic cholestasis and biliary atresia indications in Greater China.

CANbridge Pharmaceuticals founder, chairman and CEO James Xue said: “We are delighted to have dosed the first patient in our CAN108 trial in biliary atresia at Peking’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.”

A progressive inflammatory ailment of the biliary tree, biliary atresia presents in the first weeks of life and can manifest as persistent jaundice, acholic stools and dark urine. 

In March this year, the company dosed the first participant in the Phase Ib/II trial of CAN106 for treating paroxysmal nocturnal haemoglobinuria in China.