Lund, Sweden January 27, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases today announced that the patient enrollment in an investigator-initiated phase 2 study to evaluate safety, tolerability and efficacy of imlifidase in 15 patients with severe Anti-GBM antibody disease has now been completed. A first data read out is expected in the third quarter of 2020.

"I am very pleased that we have now completed the enrollment of patients in the Anti-GBM antibody disease study. This marks an important milestone in Hansa Biopharma's efforts to develop potentially lifesaving and lifealtering therapies for patients with rare immunological diseases within a range of therapeutic areas, where there is a significant unmet medical need", says Søren Tulstrup, President and CEO, Hansa Biopharma. "Anti-GBM is the first IgG-mediated disease outside transplantation, where imlifidase is being investigated to potentially stop an immunologic attack".

Anti-GBM antibody disease, also known as Goodpasture's disease, is a severe kidney disease where the immune system mistakenly develops IgG-antibodies, resulting in an acute immune attack on the kidneys and in some patients also on the lungs. Severe Anti-GBM antibody disease may progress to renal failure or death. Most of the patients are experiencing significant loss of kidney function requiring chronic dialysis and kidney transplantation. Anti-GBM antibody disease affects roughly one in a million annually.

Hansa Biopharma was granted orphan drug designation for imlifidase for Anti-GBM antibody disease in both the EU and the US in 2018.