Top line results from the Swedish ongoing Phase II study with IdeS in sensitized patients presented
The ongoing and fully recruited Phase II study at Uppsala University Hospital and Karolinska University Hospital in Huddinge, Sweden, includes 10 patients who received a single dose of IdeS (0.25 or 0.5 mg/kg) before kidney transplantation. The study’s primary focus is to evaluate safety and tolerability of Hansa Medical’s candidate drug IdeS in sensitized kidney transplantation patients. The study is also aimed at identifying an IdeS dose that results in anti-HLA antibody levels acceptable for transplantation within 24 hours from dosing. Patients in the study are followed for six months after transplantation to continue to evaluate drug safety and kidney function. The study is expected to be finalized in Q4 2016.
Professor Tufveson concludes in his presentation that IdeS treatment is a suitable way to achieve rapid and effective desensitization allowing transplantation in immunized patients and that a dose level of 0.25 mg/kg body weight is a suitable dose.
Two additional clinical studies with IdeS in sensitized patients are ongoing: an investigator initiated Phase II study at Cedars-Sinai Medical Center in Los Angeles and a pivotal multicenter study in the US with IdeS in refractory highly sensitized patients. Results from the multicenter study hold the potential to form the basis for filing a Biologics License Application, which is an application to the US Food and Drug Administration (FDA) for authorization to commercialize IdeS in the US. In addition, Hansa Medical is evaluating the possibility of adding various European sites to this multicenter study to better support the regulatory process at the European Medicines Agency, EMA, to gain marketing authorization of IdeS in the European market.
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 August 23, 2016 at 08.30 CET.