Policy & Regulation
Hansa Biopharma concludes enrollment in investigator-initiated phase 2 study in Anti-GBM patients
27 January 2020 -

Immunomodulatory enzyme company Hansa Biopharma on Friday announced the completion of enrollment of 15 patients under an investigator-initiated phase 2 study to evaluate the safety, tolerability and efficacy of imlifidase in severe Anti-GBM antibody disease .

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. Anti-GBM antibody disease affects roughly one in a million annually.

According to the company, the first data read out from the anti-GBM study is expected in the third quarter of 2020.

The company added that the completion of enrollment in the anti-GBM study marks an important milestone for the expansion outside transplantation.

In 2018, the company received orphan drug designation for imlifidase for Anti-GBM antibody disease in both the EU and the US.

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