CANbridge Pharmaceuticals has dosed the first subject in the Phase Ib/II clinical trial of CAN106 to treat paroxysmal nocturnal haemoglobinuria (PNH) in China.
A new, long-acting recombinant human monoclonal antibody, CAN106 attaches to and neutralises a crucial component of the complement system called C5.
The open-label, multicentre trial will assess the safety, efficacy, tolerability and pharmacokinetics/pharmacodynamics (PK/PD) of intravenous doses of CAN106 in PNH patients who are naïve to complement inhibitor therapy.
It was initiated after the company obtained approval from China’s National Medical Products Administration.
The regulatory agency based the approval on findings from a study that enrolled healthy subjects in Singapore.
In the trial, CAN106 was demonstrated to be safe and well-tolerated as well as shown to possess dose-dependent and linear pharmacokinetic exposure.
Furthermore, the results found that the treatment could efficiently hinder free C5 and CH50.
CANbridge Pharmaceuticals founder, chairman and CEO James Xue said: “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.
“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.”
A type of fatal and rare disorder, PNH occurs when the complement system is dysregulated.
PNH patients lack the proteins that typically offer protection to red blood cells, leaving them vulnerable to complement attack, which causes their destruction or hemolysis.
This results in severe anaemia, gastrointestinal pain and dysfunction, thromboembolism, fatigue, cardiac failure and even death.