Development status for IdeS
The clinical development program is currently focused on treatment prior to kidney transplantation. The long-term vision for Hansa Medical is to establish IdeS as a therapy for fast and efficient elimination of pathogenic IgG in several transplant-related indications and acute autoimmune diseases.
IdeS has been evaluated in a Phase I study in healthy subjects and in two finalized Phase II studies in sensitized patients awaiting kidney transplantation. The results from these studies demonstrate that IdeS is highly effective in reducing anti-HLA antibodies to levels acceptable for transplantation and is well tolerated.
The efficacy and safety of IdeS is currently being investigated in two ongoing Phase II studies in highly sensitized kidney transplantation patients. Patient recruitment was completed in early January 2018 to these two Phase II studies and the patients will be monitored for six months with respect to safety, kidney function and levels of donor-specific antibodies (DSA). Results from these two studies are expected by third quarter 2018.
An investigator-initiated Phase II study with IdeS in the rare and acute autoimmune kidney disease anti-GBM antibody disease is ongoing in collaboration with several European nephrology clinics. Additional Phase II studies with IdeS are being planned within acute antibody-mediated rejection (AMR) and treatment of the acute autoimmune neurological disease Guillain-Barré syndrome (GBS).