Hansa Medical, a biopharmaceutical company developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to IdeS (INN: Imlifidase) for the treatment of Guillain-Barré syndrome (GBS).

“We are pleased to receive orphan designation for IdeS in the US for the treatment of Guillain-Barré syndrome. IdeS’ fast and effective ability to cleave IgG antibodies has significant treatment potential in Guillain-Barré syndrome and we are planning a Phase II study with IdeS in this acute neurological disease”, states Ulf Wiinberg, Acting CEO at Hansa Medical AB.

Guillain Barré syndrome (GBS) is an acute autoimmune disease in which the peripheral nervous system is attacked by the immune system and IgG-antibodies. It affects 1-2 in 100,000 people annually. In February 2017, preclinical data demonstrating the treatment potential of IdeS in GBS were published. In a model of GBS, inactivation of IgG by IdeS treatment significantly promoted the recovery and reduced the degeneration of peripheral nerves. The data show that treatment with IdeS could potentially become a novel therapeutic strategy for the treatment of GBS.

IdeS, IgG-degrading enzyme of streptococcus pyogenes, is an enzyme that depletes IgG antibodies fast and effectively. Hansa Medical is developing IdeS as a proprietary treatment to enable kidney transplantation in sensitized patients, previously unable to undergo transplantation surgery due to the presence of anti-HLA IgG antibodies. Efficacy data reported from three Phase II studies have demonstrated that IdeS rapidly and significantly reduced anti-HLA antibodies, enabling transplantation. IdeS is currently being evaluated in highly sensitized patients that do not respond to available desensitization methods. Results from two ongoing studies are expected in 2018. In addition to transplantation, IdeS is being evaluated in a clinical Phase II study in the rare autoimmune disease anti-GBM antibody disease and IdeS has potential applications in a variety of additional autoimmune diseases. IdeS is protected by several patents and results of studies with IdeS have been published in a number of peer reviewed scientific journals.