Skip to main contentSkip to navigationSkip to search
HNSA (, %) SEK
Hansa Biopharma logotype

Swedish Medical Products Agency approves Hansa Medical’s clinical Phase II-study application with IdeS

Regulatory information
Hansa Medical announces the Swedish Medical Products Agency’s approval of the application to carry out a clinical Phase II-study with the drug candidate IdeS. The study’s primary objective is to investigate IdeS’ efficacy and safety in sensitised kidney transplantation patients. The Phase II-study will be conducted at Uppsala University Hospital and is scheduled to begin in the second quarter of 2014.

The drug candidate IdeS is developed for fast and efficient inactivation of circulating IgG-antibodies in sensitised patients awaiting kidney transplants. The ambition is to enable transplantation for thousands of patients with kidney disease a few minutes after distributing an intravenous injection with IdeS. In 2013, a Phase I-study on 29 healthy subjects, demonstrated that IdeS is efficacious and is well tolerated with a favourable safety profile.

The approved Phase II-study will explore IdeS’ safety and efficacy on anti-HLA antibodies in sensitised patients waiting for kidney transplants. In the second quarter of 2014, Hansa Medical will file an application for a second Phase II-study with the Swedish Medical Products Agency. The second Phase II-study will establish IdeS’ efficacy and safety in conjunction with kidney transplantation in sensitised patients. IdeS’ combined Phase II-trials will include approximately 15 patients, last for approximately 12 months and begin in the second quarter of 2014.

Sensitised patients
Defining the patient group are individuals immunized to HLA (Human Leukocyte Antigen), a ubiquitous protein on all cell surfaces. Anti-HLA antibodies constitutes an immediate barrier for transplantation of sensitised patients due to the apparent risk of transplant rejection. Sensitised 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.