I am excited and honored to join Hansa Medical. The company has created an exciting proprietary drug development platform based on IgG-modulating enzymes for transplant related indications and acute autoimmune diseases. The team at Hansa Medical has successfully designed and managed a series of clinical studies with its lead compound IdeS, demonstrating its ability to enable lifesaving kidney transplantation in highly sensitized patients, an indication area where there is significant unmet medical need. With a growing body of clinical evidence, opportunities to broaden the use of IdeS to a multitude of indications and next-generation drug candidates in development, Hansa is well positioned to become a fast growing biopharmaceutical company.
At the beginning of the year, enrollment was finalized in the two ongoing Phase II studies with IdeS in highly sensitized kidney transplant patients. A total of 18 patients were enrolled in the international multicenter study Highdes, and 17 patients were enrolled in the US investigator-initiated study at Cedars-Sinai Medical Center led by principal investigator, Professor Stanley Jordan. Treatment with IdeS enabled kidney transplantation for all 35 patients in the two studies by turning positive cross-match tests for donor specific antibodies into negative cross-match tests. The unique and novel mechanism of action of IdeS in depleting IgG antibodies enabled kidney transplantation for the patients in these two studies where previous attempts at desensitization had failed. We have managed to transplant patients that have been on dialysis for more than 20 years. All treated patients will be monitored for six months to collect follow-up data with respect to safety, kidney function and frequency of antibody mediated rejection (AMR). We expect to have the six-month follow up data from all 35 patients by end of third quarter this year.
Meanwhile, we are preparing for meetings with both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to discuss a potential route towards filing of a BLA (Biologics License Application) in the US and/or filing of an MAA (Market Authorization Application) in Europe at end of 2018 or early 2019. In addition to the compelling data demonstrating the efficacy and safety of IdeS in enabling kidney transplantation, important items for these discussions will be the six-month follow-up data, validation of the IdeS manufacturing process, and the significant medical need for these highly sensitized patients who today have very limited chances, if any, to be transplanted.
In parallel with our progress in kidney transplantation, we are equally determined to pursue the therapeutic potential of IdeS in other indications. We believe that the fast onset and efficacy of IdeS has the potential to significantly contribute to the critical care in several transplant-related indications and acute autoimmune diseases.
A Phase II study is ongoing in anti-GBM antibody disease, a rare and acute autoimmune kidney disease, where approximately two thirds of patients lose their kidney function, resulting in the need of chronic dialysis. As of end of March, 2018, seven patients had been included in the investigator-initiated Phase II study in severe anti-GBM. Limited follow-up data is currently available from five of these seven patients who have all responded favorably. IdeS appears to be well tolerated. The study aims to enroll approximately 15 patients at clinics across Europe.
In February, the FDA granted orphan drug designation to IdeS for the treatment of Guillain-Barré syndrome (GBS), a rare acute autoimmune neurological disease. The ability of IdeS to fast and effectively cleave IgG antibodies has significant treatment potential in GBS, and we are planning a Phase II study with IdeS in this acute neurological disease.
Through my career, I have gained extensive experience in building organizations and teams in both Europe and the United States in various pharmaceutical companies, including fast growing bio- pharma companies – a scenario that I think Hansa Medical is also facing now since we are getting close to a potential launch. We will continue to strengthen our organization both in Europe and the US, naturally within R&D but we will also put a lot of emphasis on grow- ing our commercial and medical affairs infrastructure to provide further insight into currently published data from clinical studies with IdeS and prepare for a successful launch.
Hansa Medical has continued to make strong progress in delivering on its strategy and has successfully achieved several important clinical and regulatory milestones according to plan. The foundations are in place to achieve our vision of becoming a world-leading IgG-modulating company providing important, life-saving products to patients across a range of conditions where IgG plays a key role in disease progression or forms a barrier for patients to receive appropriate treatment. I look forward to updating you on our continued progress.
President and CEO of Hansa Medical
Lund, Sweden, April 25, 2018