The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Hansa Medical's IdeS for the prevention of antibody mediated organ rejection in solid organ transplant patients.
Approximately 30 per cent of the patients on the waiting lists for kidney, heart, lung and pancreas, equivalent to approximately 35 000 patients in the US, are sensitized to human leukocyte antigen (HLA). HLA sensitization is a risk factor in transplantation and a significant part of the sensitized patients are rarely considered for transplantation due to the increased risk of antibody mediated organ rejection. Hansa Medical currently conducts phase II trials with candidate drug IdeS for the prevention of antibody mediated organ rejection in kidney transplant patients.
“We are pleased to receive orphan designation for IdeS in the US as HLA sensitization constitutes a significant barrier for transplantation for thousands of patients annually. We believe that IdeS has the potential to enable transplantation for these patients,” states Göran Arvidson, CEO at Hansa Medical AB.
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. IdeS aims to degrade immunoglobulin G (IgG) and has been tested for safety and efficacy in numerous in vitro and in vivo models. During 2013, a phase I clinical trial on 29 healthy subjects was conducted, demonstrating IdeS as efficacious and well tolerated with a favourable safety profile. During 2014, a phase II study in 8 sensitized patients awaiting kidney transplantation was conducted. Preliminary data show that IdeS is effective in reducing anti-HLA antibody levels in highly sensitized patients on the kidney transplant waitlist. The study shows that IdeS has the capacity to make sensitized patients eligible for transplantation by decreasing HLA antibodies to levels acceptable for transplantation. In addition to transplantation, IdeS has potential applications in a variety of rare autoimmune diseases. IdeS is protected by several patents and results of studies with IdeS have been published in a number of peer reviewed medical and scientific journals.