Acute Autoimmune Disease Battling Bacterial Enzyme Gets FDA Backing
The Orphan Drug Designation awarded by the FDA normally deals with drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
The status has now been awarded to a drug, IdeS, an IgG-degrading enzyme derived from streptococcus pyogenes. Developed by Hansa Medical, a biopharmaceutical company developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases, the drug is aimed at patients with Guillain-Barré syndrome (GBS).
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 was originally designed to enable kidney transplants in sensitized patients that couldn’t undergo the procedure. IdeS significantly reduced antibody levels during a Phase II study to allow transplantation to go ahead. The company is now eying up autoimmune diseases, with Guillain-Barré syndrome its first target.
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.
“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.
