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The Hansa Medical candidate drug IdeS has enabled successful kidney transplantation

Regulatory information
A successful kidney transplantation of an HLA sensitized patient has been accomplished following desensitization with the candidate drug IdeS at Uppsala University Hospital. The patient is enrolled in the ongoing Phase II study sponsored by Hansa Medical with the primary objective to study IdeS’ capacity to reduce levels of anti-HLA antibodies in sensitized patients.

HLA sensitized patients rarely become transplanted due to the immediate risk of transplant rejection caused by donor specific anti-HLA antibodies. However, following treatment with IdeS the now transplanted patient became eligible for deceased donor transplantation after treatment with IdeS. The cross match test, determining if the patient was compatible with the deceased donor, showed that the donor specific antibodies had been completely inactivated by the IdeS-treatment making the cross match negative. The patient was then successfully transplanted and the transplanted kidney is now perfectly functional.

“We have demonstrated, for the first time, that IdeS can enable transplantation for patients burdened by anti-HLA antibodies as the primary obstacle to transplantation. I am very happy that we by treatment with IdeS, have managed to help this patient to become transplanted,” comments Emanuel Björne, CEO Hansa Medical AB (publ).

Thousands of sensitized patients around the world live in a hopeless wait, hindered from transplantation due to high levels of anti-HLA antibodies. These patients face long-term dialysis, associated with significantly shortened life expectancy and reduced quality of life. The goal of Hansa Medical is that all these patients shall be transplanted through treatment with IdeS.

“We have purposefully brought our unique IdeS-concept from discovery, through phases of research and development into effective and safe treatment of a patient. This brings hope to patients in need and is a major success for my dedicated colleagues here at Hansa Medical and at Uppsala University Hospital as well as for our long term committed owners whose investments made this possible,” concludes Emanuel Björne, CEO Hansa Medical AB (publ).

More on IdeS
The candidate drug IdeS is developed as a fast, effective and safe method to deactivate anti-HLA antibodies in sensitized patients prior to kidney transplantation. During 2013, a successful Phase I-study on 29 healthy subjects was performed, demonstrating IdeS as efficacious and well tolerated with a favourable safety profile. The purpose of the ongoing Phase II-study is to explore IdeS’ safety and efficacy on anti-HLA antibodies in sensitized patients awaiting kidney transplantation. The objective is to generate significant clinical data in order to enable a pivotal phase III trial. In total, approximately 20 patients will be enrolled in two separate phase II studies planned to last until the second quarter of 2015.