Sanifit receives FDA IND approval
Sanifit announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application to begin the Phase 1b/2 clinical study of SNF472 in haemodialysis patients. If successful, SNF472, an intravenous (i.v.) formulation of the hexasodium salt of myo-inositol hexaphosphate, has the potential to become the first FDA-approved drug for the treatment of calciphylaxis.
SNF472 is being developed by Sanifit as an orphan drug for the treatment of calciphylaxis (also referred to as calcific uremic arteriolopathy (CUA)). It is also being developed for the prevention of cardiovascular events (including mortality) by inhibiting the progression of cardiovascular calcification (CVC) in patients with end-stage renal disease (ESRD) undergoing haemodialysis (HD).
Currently, the only treatments available for calciphylaxis patients are off-label and have serious limitations.
“FDA IND approval represents a significant milestone for Sanifit, and continues our progress toward developing and commercializing a new therapy to treat haemodialysis patients with this devastating and life-threatening disease, as is calciphylaxis,” said Sanifit CEO Joan Perello. Sanifit is committed to conducting a full program of clinical trials to expand treatment options for SNF472 and to explore additional indications.