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CANbridge announces positive top-line data from Maralixibat/LIVMALLI in a Phase 3 trial for the treatment of progressive familial intrahepatic cholestasis

 Last Update: 2022-11-04
 Source: Internet
 Author: User

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CANbridge Pharmaceuticals Inc.
('CANbridge, stock code: "1228.
HK"), is a global biopharmaceutical company that is a global leader in the research, development and commercialization
of innovative therapies.
The Company announced on October 27 that its partner Mirum Pharmaceuticals Inc.
(NASDAQ: MIRM) released LIVMARLI^® (maralixibat) oral solution has achieved positive top-line data
in the Phase 3 MARCH study evaluating the safety and efficacy of progressive familial intrahepatic cholestasis (PFIC).

PFIC has been included in the First Batch of Rare Diseases Catalogue issued by the National Health Commission and five ministries in 2018
.
CANbridge has an exclusive license to develop and commercialize maralixibat (CAN108) in Greater China for the treatment of three rare liver diseases
, including biliary atresia (BA), Arajeri syndrome (ALGS) and PFIC.
CANbridge oversees CAN108's Phase II EMBARK study
for the treatment of BA in China.
According to the pilot policy of Hainan Boao Lecheng International Medical Tourism Pilot Zone, CAN108 has been approved for the treatment of ALGS
in the zone.

Dr.
Qun Xue, Founder, Chairman and Chief Executive Officer of CANbridge, said, "Congratulations to Mirum for the success of the clinical trial and look forward to bringing new treatment options
to patients with rare liver disease in Greater China with continued joint efforts.
”

About CAN108 (Maralixibat oral solution)

Maralixibat oral solution is a virtually unabsorbed ileal bile acid transporter (IBAT) inhibitor that blocks the bile acid enterohepatic gyrus, reduces bile acid levels in the liver and serum, reduces the resulting liver damage, and relieves itching
.
Maralixibat oral liquid is currently the first and only FDA-approved drug
for the treatment of cholestatic pruritus in patients 1 year of age and older with Arajri syndrome (ALGS).

In addition to ALGS, the development of other indications for cholestatic liver disease is also in advanced clinical development, including progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA).

Among them, ALGS and PIFC have been awarded breakthrough therapy and rare disease innovative drug designation
by the FDA.

CANbridge has obtained exclusive authorization for the development and commercialization of ALGS, PFIC, and BA in Maralixibat Oral Liquid Greater China, and the domestic marketing application (NDA) of CAN108 for the treatment of Arajri syndrome has been officially accepted by the National Medical Products Administration (NMPA) and included in the priority review
.

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