Last patient included in IdeS clinical Phase II study
Hansa Medical announces inclusion of the last patient in a clinical Phase II study with the drug candidate IdeS. The study is carried out at Uppsala University Hospital targeting IdeS’ safety and efficacy on anti-HLA antibodies in sensitized patients.
The purpose of the study is to explore IdeS’ safety, tolerability and efficacy on anti-HLA antibodies in sensitized patients awaiting kidney transplantation. A total of eight patients have been included in the study. Patients have been treated with one or two doses of IdeS.
It has previously been reported on August 18, 2014, that a successful kidney transplantation of an HLA sensitized patient was accomplished following desensitization with IdeS.
Preliminary data from the study are expected to be announced before the end of January, 2015.
IdeS is a bacterial enzyme that cleaves human IgG antibodies, a unique molecule with a novel mechanism. IdeS degrades all IgG specifically, swiftly and efficiently. IdeS 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 clinical trial in sensitized patients awaiting kidney transplantation was initiated, to be reported during 2015. IdeS has potential indications within transplantation and a broad variety of rare autoimmune diseases, where it addresses unmet medical needs. IdeS is protected by several patents and has been published in numerous peer review journals.
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. Major shareholders are Farstorps Gård AB and Nexttobe AB.
For further information, please contact:
Hansa Medical AB
Fredrik Lindgren, President and CEO
Mobile: +46 705 61 61 77