After the recent approval of the Orphan Status by the European Medicine Agency (EMA), the Food Drug Administration (FDA) has granted Orphan Drug Designation for hexasodium phytate (the active principle of Sanifit`s lead compound SNF472) for the treatment of Calciphylaxis in December 2012.
Calciphylaxis is a rare disease with a high mortality (55% in the first year after diagnosis). It usually presents with severe, painful calcified skin ulcers, as well as calcification of blood vessels and other soft tissues. Patients would greatly benefit from an effective medicine and Sanifit is cooperating with leading experts to optimize the development of SNF472 for this indication. Clinical trials are planned to commence in 2014.
This is a major step forward in our efforts towards a new approach to calcification disorders, especially in severe and life-threatening diseases. SNF472 is also being developed for the prevention of cardiovascular calcification, a major clinical problem in patients with end-stage renal disease requiring dialysis.