Chugai Pharmaceutical has developed a groundbreaking treatment named crovalimab, a humanised monoclonal antibody targeting complement C5, designed particularly for adults and adolescents (aged 12 and above) suffering from paroxysmal nocturnal haemoglobinuria (PNH) who haven't undergone previous complement inhibitor therapy.
Crovalimab, developed through genetical recombination, is an anti-C5 recycling antibody formulated using Chugai’s innovative Recycling Antibody technology. This technology allows for pH- dependant antigen binding, enhancing the antibody's ability to bind to the target multiple times, thereby prolonging its efficacy compared to traditional antibodies.
By specifically targeting C5, a crucial component of the complement system, crovalimab is anticipated to effectively regulate complement activity.
Moreover, crovalimab offers the advantage of subcutaneous administration, potentially reducing treatment burden for patients and caregivers. Its unique binding site on complement C5 makes it a promising option for individuals with a specific C5 gene mutation found predominantly in Asian populations, particularly affecting around 3.2 percent of Japanese PNH patients. This mutation renders existing antibody drugs ineffective in binding to C5.
The approval of crovalimab is supported by findings from various studies, including the COMMODORE 3 study, a phase III clinical trial conducted in China, and the COMMODORE 2 study, a global phase III trial involving PNH patients who had not previously received complement inhibitor treatment.
PNH is characterised by intravascular haemolysis due to complement activation, stemming from the clonal expansion of haematopoietic stem cells with acquired mutations in the PIG-A gene. Its symptoms vary, including haemoglobinuria, thrombosis, and haematopoietic failures akin to aplastic anaemia. PNH can lead to complications such as chronic kidney disease and pulmonary hypertension.
