TikoMed AB, a Swedish biotechnology company focused on development and commercialization of innovative treatments for immune diseases and cell therapies, announced that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection of pancreatic islet transplantation by the U.S. Food and Drug Administration (FDA). The FDA’s orphan drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in the U.S. The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the U.S. after product approval.IBsolvMIR is a unique new treatment which could transform islet cell transplantation into a standard treatment for severe type 1 diabetes patients with unstable diabetic conditions. TikoMed’s product IBsolvMIR improves the survival of transplanted cells by inhibiting a destructive immunological reaction, and through stimulation of growth factors. IBsolvMIR has the ability to improve the transplantation outcome by preventing destruction of the insulin producing islet cells by the immune system. Successful islet transplantation has the potential to make severe type 1 diabetics insulin independent and aids them in avoiding hypoglycemic crises.
In a previous phase I study, IBsolvMIR was well tolerated by healthy volunteers, with no dose-limiting adverse effects documented and a on going phase II clinical study has gained a $15 million grant from the National Institutes of Health (NIH) through Uppsala University, Sweden.
