First patient in IdeS phase II study transplanted
Hansa Medical AB (publ) today announced that the first patient after treatment with IdeS in a recently initiated Phase II study has been transplanted from a deceased donor.
The phase II study that can include up to 10 patients is performed at Uppsala University Hospital and Karolinska University Hospital. The study will evaluate the safety, tolerability and efficacy of IdeS in kidney transplantation of sensitized patients. The patient was treated and transplanted in Uppsala.
The study is also aimed at identifying the appropriate dose that in the majority of patients will result in anti-HLA antibody levels acceptable for transplantation within 24 hours from dosing. It is expected that top-line results will be available around half-year 2016.
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. IdeS aims to degrade immunoglobulin G (IgG) and has been tested for safety and efficacy in numerous in vitro and in vivo models. During 2013, a Phase I clinical trial on 29 healthy subjects was conducted, demonstrating IdeS as efficacious and well tolerated with a favourable safety profile. During 2014, a Phase II study in 8 sensitized patients awaiting kidney transplantation was conducted. Preliminary data show that IdeS is effective in reducing anti-HLA antibody levels in highly sensitized patients on the kidney transplant waitlist. The study shows that IdeS has the capacity to make sensitized patients eligible for transplantation by decreasing HLA antibodies to levels acceptable for transplantation. In addition to transplantation, IdeS has potential applications in a variety of rare autoimmune diseases. IdeS is protected by several patents and results of studies with IdeS have been published in a number of peer reviewed medical and scientific journals.
The information in this press release is disclosed pursuant to the Securities Markets Act or the Financial Instruments Trading Act. The information was released for public disclosure on June 15, 2015, at 08.30 CET.
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO and CFO
Mobile: +46 70-390 85 30
Christian Kjellman, Ph.D
Chief Scientific Officer
Mobile: +46 705 717417
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation and rare autoimmune diseases. Other projects include HBP (a market introduced diagnostic marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's share (HMED) is listed on Nasdaq First North in Stockholm with Remium Nordic AB as Certified Adviser.