Hansa Medical is breaking new ground with IdeS, an immunomodulatory enzyme specifically inactivating IgG antibodies. In an ongoing clinical Phase II trial, Hansa Medical with collaborators at Uppsala University Hospital recently accomplished a successful kidney transplantation of an HLA sensitized patient following treatment with the candidate drug IdeS.
If the development of IdeS as a single-dose treatment breaking the antibody barrier in HLA sensitized patients is successful through the ongoing clinical trials, Hansa Medical will bring a significant and positive change to transplantation surgery and dramatically change the lives of patients otherwise facing long-term dialysis.
Background: a need for change Patients with severe renal impairment must be treated using dialysis in order to survive, through a process that must be repeated several times a week and which lasts about three hours each time. Thereafter, patients require a recovery period of between two and 24 hours. This makes it hard for the patients to live their lives as they wish, ruling out many activities and making traveling next to impossible. In addition, one of the major drawbacks with dialysis is the increased risk of the patients developing cardiovascular diseases. Life-expectancy is always dramatically reduced with long-term dialysis. Hardly surprising, kidney transplantation surgeons all over the world are desperately crying out for a treatment that will enable kidney transplantation in sensitized patients. And Hansa Medical may have the answer.
Major pharmaceutical breakthrough A successful Phase I study of IdeS finalized in January 2014, demonstrated that the enzyme is safe, effective and fast in inactivating circulating IgG in healthy subjects. Encouraged by the Phase I results, a Phase II trial in sensitized patients was initiated. In August 2014, Hansa Medical with collaborators at Uppsala University Hospital accomplished a successful kidney transplantation of an HLA sensitized patient following IdeS treatment. “The IdeS combination of properties could very well revolutionise the care of thousands of sensitized patients annually”, says Hansa Medical CEO Emanuel Björne. Approximately 35 000 kidney transplants are performed annually in USA and Europe alone. Globally, the figure lands on total of approximately 73 000 kidney transplants each year. “15 to 30 per cent of patients (on a global scale) in need of a kidney transplant are sensitized. Thus, IdeS could be a potential treatment for several thousands of patients in the USA and Europe alone”, informs Emanuel Björne. The market opportunities are evident.
Phase II studies to commence shortly Recent trends indicate that the market for rare diseases is expanding rapidly. Many companies are now reaping the benefits of having launched successful treatments to ultra-rare diseases. And Hansa Medical is at the core of this intensive development. With several successful projects, some of which already out-licensed for further development with other companies, Hansa Medical looks to the future with IdeS and other compounds. “The accomplished transplantation of an HLA sensitized patients through treatment with IdeS is undoubtedly our most extensive single success so far”, says Emanuel Björne, “We also see great therapeutic potential for IdeS in the treatment of several acute but rare autoimmune diseases like Guillain-Barré syndrome and Goodpasture’s disease and we are planning to investigate IdeS in this field through clinical trials as well”, concludes Emanuel Björne.
Hansa Medical is based in Medicon Village in Lund and the company’s share is publicly traded at NASDAQ OMX First North under the ticker symbol HMED.