Recently, Hansa Biopharma announced that the first patient has been treated with imlifidase—a first-generation immunoglobulin G-cleaving enzyme—in an investigator-initiated phase 2 study for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

President and CEO of Hansa Biopharma, Søren Tulstrup, expressed his enthusiasm about this advancement. “This is an important step forward in the development of our technology platform and pipeline of drug candidates for rare immunologic diseases and conditions. Our lead molecule imlifidase has the potential to address areas of high unmet need in the autoimmune disease space, as demonstrated by our clinical studies in anti-glomerular basement membrane (“anti-GBM”) 1 disease and Guillain-Barré syndrome (“GBS”). We look forward to the results of this study in yet another autoimmune disease and are excited about the potential for imlifidase to help even more patients suffering from serious autoimmune diseases and conditions.”

The phase 2 trial, conducted at Charité Universitätsmedizin in Berlin, Germany, is a single-center, single-arm study led by Adrian Schreiber, MD, and Philipp Enghard, MD. The primary objective is to assess the efficacy and safety of imlifidase when administered together with standard of care for patients with pulmonary hemorrhage due to severe AAV.

“There are very few treatment options to achieve rapid control of disease activity for patients affected by ANCA-associated vasculitis and we believe imlifidase constitutes a promising opportunity for these antibody-related disorders. Thanks to its almost immediate and highly effective action, imlifidase has the potential to be a powerful candidate as new treatment for ANCA-associated vasculitis, particularly in patients with severely active disease,” said Dr. Enghard.

Read more about experimental therapies for AAV

The trial will enroll 10 patients with severe AAV and acute respiratory distress syndrome due to pulmonary hemorrhage, who will receive imlifidase in addition to standard immunosuppression and intensive support care.

The efficacy and safety of imlifidase will be evaluated based on various parameters, including ANCA antibody seroconversion and titers, adverse events, mortality, as well as improvement in lung and renal function over a 6-month observation period.


First patient treated with imlifidase in an investigator-initiated phase 2 study in ANCA-associated vasculitis. News release. Hansa Biopharma AB; July 19, 2023.