Hansa Investment Company Limited announced first patient treated with imlifidase in an investigator-initiated phase 2 study in anti-neutrophil cytoplasmic antibody ("ANCA")-associated vasculitis. This is the first study evaluating imlifidase, Hansa's first-generation IgG-cleaving enzyme, in this patient population. The study is a single center, single arm, phase 2 trial led by Dr. Adrian Schreiber and Dr. Philipp Enghard, at Charité Universitätsmedizin, Berlin, Germany.

The primary objective of the study is to assess efficacy and safety of imlifidase together with standard of care in the treatment of patients with pulmonary hemorrhage due to severe ANCA-associated vasculitis. A total of 10 patients with severe ANCA-associated vasculitis and Acute Respiratory Distress Syndrome due to pulmonary hemorrhage will be treated with imlifidase on top of standard of care (consisting of standard immunosuppression as per center protocol and intensive support care). Efficacy and safety of imlifidase will be assessed by evaluating ANCA antibody seroconversion and titers, adverse events, mortality, as well as amelioration of lung and renal function over a 6-month observation period.

ANCA-associated vasculitis is a group of conditions that affect approximately 30 people in a million annually in the EU and US. It is characterized by the presence of IgG anti-neutrophil cytoplasmatic antibodies directed against antigens expressed by the neutrophils, a type of white blood cell part of the body's immune system response. The consequent activation of neutrophils by the ANCA antibodies causes blood vessel damage5 that can affect multiple organs, most frequently lungs and kidneys, where it leads to rapidly deteriorating organ function.

The progress of the disease results in end stage kidney disease in 25% of patients.6 The most severe cases involving lungs lead to pulmonary hemorrhage with consequent respiratory failure.