It is a privilege and an honor to join a company that over the last couple of years has - step by step - created an exciting platform within IgG-modulating enzymes for transplantation and acute autoimmune diseases. The team at Hansa Medical has successfully designed and carried out a series of clinical studies with its lead compound IdeS and at the same time created a strong pipeline in a drug based on IdeS.
I am very impressed with the science and the development strategy along with the quality and ambition of the team and I look forward to working with them as we continue to build on the significant achievements accomplished to date.
Our focus will be on completing the development of IdeS in highly sensitized patients and the ongoing Phase II study in anti-GBM as well as initiating additional Phase II studies in closely related transplant indications and in autoimmune disease. In addition, we will continue the development of our novel IgG-eliminating enzymes as well as explore development of potential applications in oncology of these enzymes.
We still have a number of milestones to reach before IdeS is available on the market. During 2018 we plan to continue discussions with both the FDA and EMA regarding the regulatory path to approval for IdeS in transplantation. In addition to the convincing data demonstrating the efficacy and safety of IdeS in enabling kidney transplantation, important items for these discussions will be six-month follow-up data from our Highdes-study, further optimization of the manufacturing process, and the significant medical need for these highly sensitized patients who today have very limited chances, if any, to be transplanted.
We are in a strong and unique position in the development of our novel immunomodulatory enzymes. Our vision is to become a world-leading IgG-modulating company and bring our products to patients across a range of conditions where IgG plays a key role in disease. I look forward to informing you in more detail on the progress in our development programs. Very interesting times lie ahead.
President and CEO of Hansa Medical
April 11, 2018