BEIJING & CAMBRIDGE, Mass.– CANbridge Pharmaceuticals, Inc. (“CANbridge,” stock code 1228.HK), a China-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, announced that the first patient has been dosed in the CAN106 Phase 1b/2 trial for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in China.
The multi-center, open-label, Phase 1b/2 study to evaluate the tolerability, efficacy, safety and PK/PD of CAN106 administered intravenously to complement inhibitor treatment-naïve PNH patients, is under the direction of principal investigator, Dr. Bing Han, Director of Hematology, at the Peking Union Medical College Hospital.
CAN106 was previously shown to be safe and well-tolerated, with dose-dependent and linear pharmacokinetic exposure, in a study of healthy volunteers in Singapore. The data also showed that free C5 and CH50 could be effectively inhibited. Based on these results, China’s National Medical Products Administration approved the CAN106 Phase 1b/2 trial for the treatment of patients with PNH.
“We are pleased to have dosed the first patient in the CAN106 PNH trial in China so soon after reporting the first human data validating CAN106 as a potential treatment for PNH and other complement-mediated diseases,” said James Xue, Ph.D., Founder, Chairman and CEO, CANbridge Pharmaceuticals Inc. “We look forward to working with the Peking Union Medical College Hospital, one of China’s leading research institutions, with whom we recently signed a rare disease research collaboration, and to bringing this potential new treatment to patients in China, where access to anti-C5 therapies is limited, leaving them with few treatment options.”
