Hansa Medical AB announces the formation of a medical advisory board for IdeS in anti-GBM disease
The members of the medical advisory board for anti-GBM disease include:
Dr Mårten Segelmark, M.D. is Head of the Division of Drug Research (LÄFO) and Professor in Nephrology at the Department of Medical and Health Sciences (IMH), Linköping University. Dr. Segelmark received his medical degree from Lund University and completed fellowship at University of North Carolina at Chapel Hill before being appointed associate professor in Clinical Nephrology and senior consultant in Nephrology at Lund University Hospital. Dr Segelmark’s research is focused on the role of autoantibodies for the diagnosis and pathogenesis of glomerulonephritis and systemic vasculitis and he is a leading expert in anti-GBM disease. He has published more than 100 peer-reviewed journal articles, book chapters, and reviews.
Dr Wladimir Szpirt, MD is a specialist in nephrology at Copenhagen University hospital, Denmark. Dr Szpirt received his degree and internal fellowship at Copenhagen University hospital. He is a member of ethical committees, steering committees and GCP societies as well as a number of professional societies within kidney-and autoimmune disease, including becoming the president for the International Society for Apheresis. Dr Szpirt’s research interest is in vasculitis, kidney disease and clinical trials and he has an extensive list of publications within this field.
Dr. David RW Jayne, MD is Director of the Vasculitis and Lupus Clinic and Reader in Vasculitis at the University of Cambridge, UK. Dr. Jayne received his bachelor of surgery degree and medical degree from Cambridge University, England and postgraduate training at several London hospitals and Harvard University. He is on the editorial board of 7 journals and serves as a referee for 45 journals. He is a medical advisor to UK, US and EU regulatory bodies, patient groups, and professional organizations and has published more than 200 peer-reviewed journal articles, book chapters, and reviews. Dr Jayne’s research is focused on clinical evaluation of newer immunotherapeutics in vasculitis, lupus and immune-mediated renal disease and he coordinates international clinical research vasculitis network (EUVAS) and multi-center randomized controlled trials.
About anti-GBM disease (Goodpasture’s Disease)
Rapidly progressive glomerulonephritis and bleeding from the lungs became known as Goodpasture’s syndrome, based on a case report from 1919 by the pathologist Ernest William Goodpasture (1). Goodpasture’s syndrome or anti-GBM disease is a rare autoimmune disease (incidence 0.5-1 per million) in which IgG antibodies bind to the glomerular basement membrane resulting in rapidly progressive glomerulonephritis often associated with pulmonary hemorrhage (2). The diagnosis of anti-GBM disease is based on the detection of anti-GBM antibodies in conjunction with clinical symptoms. Anti-GBM disease has a poor prognosis and rapidly progressive glomerulonephritis combined with lung hemorrhage often results in death of the patient if not treated. Despite treatment less than 30% of the patients survive with a preserved kidney function and among the surviving patients a majority end up in dialysis waiting for kidney transplantation. Early diagnosis and rapid treatment are important to stabilize kidney function and decrease lung bleeding. Current treatment aims to remove antibodies from the blood (plasmapheresis), to slow the production of anti-GBM antibodies (chemotherapy) and halt inflammation (glucocorticoids), thereby lowering disease activity.
(1) Goodpasture EW. (1919) Am J Med Sci;158:863.
(2) Hellmark T, Segelmark M. (2014) J Autoimmun.;48-49:108–12.
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. 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 favorable safety profile. During 2014, a phase II clinical trial in sensitized patients awaiting kidney transplantation was initiated, to be reported during 2015. In addition to transplantation, IdeS has potential indications within a variety of rare autoimmune diseases including anti-GBM disease. IdeS is protected by several patents and has been published in numerous peer review journals.