Hansa Medical announces that the first patient has been recruited and treated in a Phase II clinical study with IdeS in the acute autoimmune disease acquired Thrombotic Thrombocytopenic Purpura (TTP) at University College Hospital in London.
Acquired TTP is a severe and acute autoimmune blood disorder in which the presence of autoantibodies can result in systemic life threatening micro-clotting in vital organs. The Hansa Medical-sponsored study with IdeS in TTP is an open-label study to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of IdeS in asymptomatic patients with acquired TTP.
The patients in the study will have low ADAMTS13 activity. ADAMTS13 is a significant component in the coagulation system. An important goal of the study is to investigate if one dose of IdeS results in increased ADAMTS13 activity by cleaving ADAMTS13 autoantibodies. The Clinical Investigator, Dr. Marie Scully, consultant haematologist at UCLH, is a leading expert in patient care and clinical research in TTP.
The study will include up to six patients with acquired TTP and low ADAMTS13 activity who are asymptomatic at the time of enrolment into this study. The study is expected to be completed during 2017.
“This novel therapy, initially investigated to determine safety and efficacy, could provide an innovative treatment for acute TTP, clearing the antibodies against ADAMTS 13, aiding response to remission and reducing morbidity and mortality”, says Dr. Scully, who is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre.
“We are happy to now announce our progress into the autoimmune space through the initiation of this explorative Phase II trial with IdeS in acquired TTP. The effective and fast IgG-cleaving mode-of-action of IdeS makes it highly relevant to evaluate the efficacy and safety of IdeS in this potentially devastating acute condition“, says Göran Arvidson, CEO of Hansa Medical AB.