CANbridge Announces Full Enrollment Reached in China Region of the Global LIVMARLI® (CAN108) EMBARK Phase 2 Study in Biliary Atresia
CANbridge Pharmaceuticals, a leading China-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, announced that the China region of the global Phase 2 EMBARK study of LIVMARLI® (maralixibat) oral solution (CAN108) in biliary atresia (BA) is fully enrolled, with nearly twice the expected number of patients. This global, multi-center, randomized controlled Phase 2 study, evaluating the efficacy and safety of LIVMARLI in patients with BA after Kasai surgery, is sponsored by Mirum Pharmaceuticals, Inc. and has also completed enrollment across the other global locations where the trial is open.
CANbridge has an exclusive license agreement for the development, commercialization and manufacturing, under certain conditions, of LIVMARLI in Greater China. In this region, CANbridge has the right to develop and commercialize LIVMARLI for three indications: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA). The National Medical Products Administration (NMPA) approved LIVMARLI for the treatment for ALGS under the Early and Pilot Implementation Policy in the Boao Lecheng International Medical Tourism Pilot Zone in China, allowing its use in the zone prior to national marketing authorization. LIVMARLI has been granted priority review by the NMPA for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age or older, with a potential for approval in the first half of 2023. CANbridge also expects to file an NDA for LIVMARLI for the treatment of PFIC with the NMPA soon.
“Enrollment in the LIVMARLI BA trial in China is nearly double what we had anticipated, which points to the dire need of effective treatments for this disease,” said Gerry Cox, MD, PhD, chief development strategist and interim chief medical officer, CANbridge Pharmaceuticals. “We are pleased to have met, and exceeded, full enrollment in this trial and look forward to the continued development of this promising treatment for patients in Greater China.”
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