CANbridge Pharmaceuticals Inc. announced that results from its CAN106 Phase 1 trial were presented at the 2022 European Hematology Association Congress, in Vienna, Austria, on June 10th. The same data will also be presented at the 14thInternational Conference on Complement Therapeutics, June 17-22, in Rhodes, Greece. Researchers reported that the long-acting, humanized, anti-C5 monoclonal antibody, CAN106, was safe and well-tolerated with mostly mild or moderate adverse events and no drug-related serious adverse events in this first-in-human single ascending dose study in healthy subjects.

Furthermore, CAN106 led to rapid (within 24 hours), dose-dependent reductions in free C5 and in CH50, a measure of serum hemolytic activity that reflects complement pathway activity. At the two highest doses (8 and 12 mg/kg), CAN106 achieved complete and sustained blockade of terminal complement activity, with all subjects showing a >99% reduction in free C5 and =90% inhibition of CH50. In addition, the half-life of circulating CAN106 in healthy volunteers was 31 days, which is similar to that of the approved anti-C5 agent, ravulizumab, which is dosed every eight weeks in patients.

The C5 protein is a component of the complement system, part of the innate immune system. Dysregulation or over-activity of the complement pathway is implicated in various complement-mediated diseases, including paroxysmal nocturnal hemoglobinuria (PNH).