Hansa Biopharma completes enrollment in anti-GBM
The completion of enrollment in the anti-GBM study marks an important milestone for the Company’s expansion outside transplantation. Anti-GBM is a rare immunological disease with a significant unmet medical need.
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.
For further information, please contact:
Klaus Sindahl, Head of Investor Relations
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Rolf Gulliksen, Head of Corporate Communications
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About Hansa Biopharma
Hansa Biopharma is leveraging its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer. The Company’s lead product candidate, imlifidase, is a unique antibody-cleaving enzyme that potentially may enable kidney transplantation in highly sensitized patients with potential for further development in other solid organ transplantation and acute autoimmune indications. Imlifidase is currently under review for marketing authorization by EMA. Hansa’s research and development program is advancing the next generation of the Company’s technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and also has operations in Europe and US.