BioStratum Incorporated announced that the FDA has granted Fast Track status to its lead drug candidate for diabetic kidney disease, Pyridorin.
To receive Fast Track status, a drug candidate must be intended for the treatment of a serious or life-threatening condition, and demonstrate the potential to address significant unmet medical needs for the condition.
Pyridorin, currently in Phase II clinical trials, is being developed for the treatment of diabetic kidney disease (nephropathy), a condition that affects approximately 2.1 million patients in the United States. Diabetic nephropathy is the leading cause of end stage renal disease (ESRD), which requires either kidney dialysis or kidney transplantation.
BioStratum also announced details about the clinical status of Pyridorin. The Company's ongoing U.S. Phase II safety study (PYR-206) is now fully enrolled, and two additional Phase II trials have been initiated outside the U.S. The ex-U.S. trials are six-month, escalating dose trials in type 1 and type 2 diabetic patients with mild to moderate diabetic nephropathy (PYR-205) or moderate to severe nephropathy (PYR-207).