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news.NephroGenex announced that the independent Data and Safety Monitoring Board (DSMB) for the Company’s pivotal Phase 3 study of oral Pyridorin for the treatment of diabetic nephropathy has completed the second, pre-planned six-month safety review and has unanimously recommended that the study continue without modification.
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Based on this review, the DSMB observed a continued acceptable safety and tolerability profile of Pyridorin in patients with overt diabetic nephropathy.
NephroGenex CEO and President Pierre Legault said: "We are encouraged by the recommendation of the independent DSMB review.
"We are excited by the progress of our Phase 3 trial, and the potential for Pyridorin to be an important therapy for diabetic nephropathy, a progressive disease for which there are limited treatment options."
PYR-311 is the first of two double-blind, placebo-controlled studies to evaluate the safety and efficacy of oral Pyridorin, a first-in-class compound for reducing the rate of renal disease progression in type 2 diabetic patients. The trial is being conducted under a Special Protocol Assessment (SPA) from the FDA and has also been granted Fast Track designation.
A DSMB is a committee of independent clinical research experts who review data in ongoing clinical trials with particular attention to safety. As per the study protocol, the DSMB meets every six months to examine the safety data accumulated during progress of the trial.
About Diabetic Nephropathy
Diabetic nephropathy (DN) is a leading cause of end-stage kidney disease. In the Unites States there are approximately 22 million diabetic patients, 40% of whom exhibit signs of DN. Clinically, DN is characterized by a progressive increase of protein in the urine, decrease in the glomerular filtration rate, increase in serum creatinine and ultimately End-Stage Renal Disease (ESRD) requiring dialysis or a kidney transplant. Although optimal control of blood pressure and metabolic risk factors is important in decreasing the progression of diabetic nephropathy, many diabetic patients still develop overt nephropathy and reach ESRD.
About Pyridorin
Pyridorin is an investigational compound with a distinct chemical structure that inhibits the formation of advanced glycation end-products (AGE).
AGEs have been implicated in the development of diabetic nephropathy. In people with diabetes, elevated glucose reacts with proteins to form complexes that are then deposited within the kidney leading to damage that interferes with normal kidney function. AGEs also lead to the generation of highly reactive molecules such as carbonyls and reactive oxygen species that can damage both the outside of the cell and important structures within the cell.