The U.S. FDA has granted Orphan Drug designation for DiaPep277 for the treatment of type 1 diabetes (T1D) patients with residual beta cell function. The designation of Orphan Drug status offers 7 years marketing exclusivity from the time of approval. In addition, this may present other benefits such as tax incentives, reduced user fees, and assistance for the registration process.
DiaPep277 is currently in Phase III clinical studies. A first study, which was conducted in Europe, South Africa, and Israel, met its primary endpoint based on initial results. A global confirmatory Phase III study is now being conducted in more than 120 medical centers.
DiaPep277, a unique peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60), was invented by Prof Irun Cohen and his team at the Weizmann Institute of Science in Israel. The peptide acts by modulating the immune system, thus preventing the destruction of pancreatic cells that secrete insulin and preserving their natural function. Treatment of type 1 diabetes patients with DiaPep277 may have several medical benefits including slowing the deterioration of the disease, improved metabolic control, reduction of daily insulin dose requirements, and reduction of diabetic complications.
Diapep277 was developed by Andromeda Biotech. In June 2010 Teva Pharmaceutical decided to exercise its option to invest in Andromeda Biotech receiving worldwide exclusive marketing rights to DiaPep277.