FDA Grants IBsolvMIR Orphan Drug designation in the treatment of diabetes patients in the U.S.

TikoMed AB, a biotechnology company focused on 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).

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 is in development to improve islet cell transplantation for patients with severe type 1 diabetes. An ongoing phase II clinical study has gained a $15 million grant from the National Institutes of Health (NIH) through Uppsala University, Sweden. IBsolvMIR has the ability to improve the transplantation outcome through avoiding 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 avoid hypoglycemic crises.