|NephroGenex Inc(NASDAQ:NRX) received positive Scientific Advice from the European Medicines Agency For Phase 3 program|
|By Marilyn Mullen|
|Friday, 09 January 2015 16:18|
NephroGenex Inc. (NASDAQ:NRX) has announced that the Company has received positive Scientific Advice from the European Medicines Agency (EMA) regarding their Phase 3 program with Pyridorin® in diabetic nephropathy that has been accepted by the U.S. Food and Drug Administration under a Special Protocol Assessment.
The EMA had cleared that the current Phase 3 program could be adequate to support a Marketing Authorization Application for full market approval in Europe.
Chief Executive Officer Pierre Legault said that the EMAs support of their pivotal Phase 3 trial in Pyridorin strengthens their global regulatory strategy for the very important clinical program. Diabetic nephropathy is a growing problem around the world, and Pyridorin has the potential to improve the care of the millions of patients who suffer from diabetic kidney disease and have few therapeutic options. The Company’s PIONEER program will include two identical double-blind placebo controlled Phase 3 trials. Each is so designed that is able to evaluate the safety and efficacy of Pyridorin at 300 mg twice a day compared to placebo in reducing the rate of renal disease progression in Type 2 diabetic patients. Primary efficacy endpoints are time to a 50% increase in serum creatinine levels, or end stage renal disease. The first Phase 3 study was launched in June 2014.
NephroGenex Inc. is a pharmaceutical company which is focused on the development of therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Diabetic nephropathy is a chronic, degenerative disease of the kidney caused by diabetes. Patients suffering from diabetic nephropathy progress to End Stage Renal Failure (and require dialysis) or death. There are currently no adequate treatments for this disease.