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First patient treated in Phase II study with IdeS in anti-GBM antibody disease

Regulatory information
Hansa Medical AB (publ) today announced that the first patient has been treated with the company lead drug candidate IdeS in an investigator initiated Phase II study in severe anti-GBM antibody disease.

Anti-GBM antibody disease, also known as Goodpasture’s disease, is a rare autoimmune disease where autoantibodies directed against type IV collagen cause acute inflammation of the kidney and/or the lungs. In severe anti-GBM, the disease may progress to renal failure or death.

The study (ClinicalTrials.gov identifier NCT03157037) is an open label investigator initiated Phase II study in severe anti-GBM disease with Professor Mårten Segelmark at Linköping University Hospital as Sponsor/Coordinating principal investigator. Approximately 15 patients will be recruited to the study at up to 15 clinics in Europe.

The primary objective of this study is to evaluate the safety and tolerability of IdeS in patients with severe anti-GBM disease on background of standard care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide (CYC) combined with plasma exchange (PLEX). IdeS efficacy will be assessed by evaluating renal function at 6 months after IdeS treatment. 

The information in this press release is disclosed pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the contact person stated below on June 20, 2017 at 08.00 CEST.