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Top line results from the Swedish ongoing Phase II study with IdeS in sensitized patients presented

Regulatory information
Hansa Medical AB (publ) today announced that preliminary results of the Sweden based ongoing Phase II study of IdeS were presented today by Professor Gunnar Tufveson at the 26th International Congress of the Transplantation Society in Hong Kong on August 23, 2016. The results show that IdeS has enabled kidney transplantation in all 10 out of 10 included sensitized patients. The Phase II study also shows that IdeS treatment resulted in negative cross match test in all patients, none of the transplanted patients experienced delayed graft function and all 10 transplantations resulted in very good creatinine levels.

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.