Hansa Biopharma AB announced the publication of important data from an investigator-initiated study in anti-GBM in leading nephrology journal Journal of the American Society of Nephrology. The publication of the results in JASN is a recognition of the considerable potential for imlifidase in autoimmune diseases involving pathogenic IgG. The investigator-initiated Phase 2 open-label study explored the efficacy of imlifidase for the treatment of anti-GBM disease as add-on to standard of care with pulse methylprednisolone, oral corticosteroids, cyclophosphamide and plasma exchange.

The results show that kidney function at 6 months was significantly better than in previously published cohorts, without any safety concerns. Of the 15 patients included, 10 were dependent on dialysis at enrollment. At 6 months, a total of 67% (N=10) of the included patients were dialysis independent, which is significantly better than in the historical control cohort, where only 18% had functioning kidneys.

All patients that were dialysis-independent at baseline remained so during the study. Anti-GBM disease is a rare and acute autoimmune condition which can lead to permanent kidney failure and even death. It is caused when the immune system mistakenly attacks a specific part of the kidneys called the glomerular basement membrane, damaging the kidneys and in some cases the lungs also.

Prognosis for the condition is poor, particularly because its rarity can lead to delayed diagnosis in a situation where, given the disease's acute nature, prompt treatment is very important.