Hansa Medical discontinues its Phase II study in acquired Thrombotic Thrombocytopenic Purpura (TTP)

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Hansa Medical Abdominal (Nasdaq Stockholm: HMED) today revealed that it will certainly not continue its scientific Phase II research study with IdeS in gotten TTP. The choice adheres to Hansa Medical’s evaluation of first arise from the research demonstrating a non-favourable risk advantage profile.

This choice to stop the research study has no influence on Hansa Medical’s ongoing research studies with IdeS in renal transplantation or planned researches in various other autoimmune indications.

The first data from treatment of 2 individuals with asymptomatic TTP plainly showed that IdeS successfully cleaves IgG antibodies, including all pathogenic anti-ADAMTS13 autoantibodies.

  • However, the reliable cleaving of the anti-ADAMTS13 autoantibodies did not cause a convincing positive result on the task of the ADAMTS13 enzyme in connection with the degree of damaging events observed. Both people treated in the research study experienced signs including fever, breakout and joint pain about one week after therapy, perhaps pertaining to treatment with IdeS in asymptomatic TTP-patients. The signs and symptoms were scientifically manageable as well as unforeseen based upon observations from completed and also recurring researches.Commenting on today’s news, Dr. Steven Glazer, Chief Medical Officer of Hansa Medical, stated, “Hansa Medical has a deep commitment to the growth of antibody-degrading and also antibody-modulating enzymes for usage in transplant as well as autoimmune conditions.
  • While we are disappointed that we were not able to demonstrate a persuading risk advantage account in asymptomatic patients with acquired TTP, we are hopeful regarding the clinical growth of IdeS in our lead programs, including transplant people.

These searchings for in asymptomatic TTP patients have no effects for recurring research studies with IdeS in transplant or other organized research studies in autoimmune indications. We are examining the possibility to examine the safety and security and also efficiency of IdeS in symptomatic acute patients with TTP in a different Stage II research in the future.”

Obtained TTP is an extreme and also acute autoimmune blood condition in which the presence of autoantibodies can result in systemic life threatening micro-clotting in crucial organ. The Hansa Medical-sponsored study with IdeS in TTP is an open-label research to assess the safety, tolerability, efficiency, pharmacodynamics and also pharmacokinetics of IdeS in asymptomatic clients with gotten TTP.

This information is information that Hansa Medical abdominal muscle (publ) is obliged to reveal pursuant to the Financial Instruments Trading Act. The details was sent for magazine at 09:40 am CET on December 21, 2016.

Concerning IdeS IdeS, IgG degrading enzyme of Streptococcus pyogenes, is an enzyme that depletes IgG antibodies quick as well as successfully. Hansa Medical is creating IdeS as a proprietary treatment to make it possible for kidney transplant in animated people, previously not able to go through transplant surgical treatment as a result of the presence of anti-HLA IgG antibodies.

Top-line efficacy data reported from 3 stage 2 studies have actually demonstrated that IdeS quickly as well as substantially decreased anti-HLA antibodies, making it possible for hair transplant. IdeS is presently being assessed in a multi-center study in the U.S. in highly animated people that do not react to available desensitization methods. Results from this study are expected in 2018. In addition to transplantation, IdeS has potential applications in a range of uncommon autoimmune conditions.

IdeS is secured by numerous licenses and outcomes of studies with IdeS have been released in a variety of peer examined clinical journals. Regarding Hansa Medical AB Hansa Medical is a biopharmaceutical company concentrating on novel immunomodulatory enzymes.

The lead job IdeS is a proprietary antibody-degrading enzyme in medical development, with possible use in transplant and also uncommon autoimmune diseases. Extra projects concentrate on growth of brand-new antibody modulating enzymes, as well as HBP, an analysis biomarker for forecast of serious blood poisoning at emergency situation departments that is currently presented on the market. The company is based in Lund, Sweden. Hansa Medical’s share (ticker: HMED) is provided on Nasdaq Stockholm.

For additional info, please call:

  • Hansa Medical Abdominal Muscle (Publ). Emanuel Björne, Vice President Organization Development and also Investor Relations.
  • Göran Arvidson, CHIEF EXECUTIVE OFFICER.
  • Cord Communications, Stockholm. Mikael Widell.
  • Lars Wahlström. FTI Consulting, London.
  • Julia Phillips/ Stephanie Cuthbert/ Hanna Skeppner

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