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Phase II IdeS-study initiated in Uppsala

Regulatory information
Hansa Medical announces treatment of the first patient in a Phase II study with the drug candidate IdeS. The study is carried out at Uppsala University Hospital targeting IdeS’ safety and efficacy on anti-HLA antibodies in sensitized patients.

The drug candidate IdeS is developed as a fast, safe and expedient method to deactivate anti-HLA antibodies in sensitized patients prior to kidney transplantation. The objective is to facilitate kidney transplantation for thousands of sensitized kidney patients within minutes after intravenous treatment with IdeS. In January 2014, a successful Phase I-study on 29 healthy subjects was finalized, demonstrating IdeS as efficacious and well tolerated with a favourable safety profile.

Phase II-study
The purpose of the initiated Phase II-study is to explore IdeS’ safety and efficacy on anti-HLA antibodies in sensitized patients awaiting kidney transplantation. A second Phase II-study is scheduled for Q3, 2014 aiming to establish IdeS’ efficacy and safety in conjunction with kidney transplantation in sensitised patients. The two Phase II studies on IdeS will include in total approximately fifteen patients and last about twelve months.

More on sensitized patients and HLA
This group of patients consist of individuals immunized to HLA (Human Leukocyte Antigen), a ubiquitous protein found on all cell surfaces. Anti-HLA antibodies constitute an immediate barrier for transplantation of sensitized patients due to the apparent risk of transplant rejection. Sensitized patients in need of transplantation are therefor referred to long-term dialysis, associated with increased risk of infection, cardiovascular disease and a significantly shortened life expectancy.