Pyridorin™

NephroGenex has acquired commercial rights to Pyridorin™ (pyridoxamine dihydrochloride). Pyridorin™ targets diabetes-induced carbonyl and oxidative chemistries that are a principal causative factor in the development of diabetic nephropathy and other diabetic complications. Pyridorin™ has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in two Phase 2 clinical trials, and has been awarded Fast Track status by the FDA. Pyridorin™ is one of the few drug candidates in advanced clinical trials for diabetic kidney disease.

Market and Competitive Landscape for Pyridorin™

Diabetic kidney disease afflicts about 33% of all patients with diabetes and is the major cause of ESRD. In the United States, approximately 6 million patients with diabetes exhibit signs of developing kidney disease, and more than 2.8 million have overt diabetic nephropathy. Approximately 30 to 40 percent of these patients are expected to advance to ESRD. The epidemiology for diabetic nephropathy in Europe is approximately the same as in the United States.

Diabetic nephropathy is currently treated with blood pressure medications that appear to improve kidney function largely by improving blood flow inside the small capillaries of the kidney, even in patients without hypertension. The approved antihypertensive medicines target the renin-angiotension pathway that controls intrarenal hemodynamics. No other drug class has been approved for diabetic nephropathy.

Pyridorin™ is one of the few drug candidates in advanced clinical trials for diabetic kidney disease. It is believed to be the only one targeting hyperglycemia-induced pathogenic chemistries that are believed to be a principal cause of the microvascular disease. Thus, it has unique promise against the fundamental causes of diabetic nephropathy.

Diabetic nephropathy is the leading cause of ESRD. Approximately 40% of ESRD is the result of diabetic kidney disease. ESRD is the largest single cost item in the Medicare budget. A critical medical need exists for treatments that slow the progression of diabetic nephropathy and significantly delay the onset of ESRD.