The Swedish Medical Products Agency has approved Hansa Medical’s clinical phase II-study application 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.
Source: Hansa Medical