NephroGenex Finds The Right Beat...

(RTTNews) - NephroGenex Inc. (NRX), which is down nearly 60 percent year-to-date, got a nice boost in Tuesday's extended trading following positive results from a thorough QT/QTc (TQT) cardiac safety study of Pyridorin - the company's phase III drug candidate for diabetic nephropathy.

Diabetic nephropathy, which is the leading cause of chronic kidney disease, is a complication of diabetes. Pyridorin works by targeting and scavenging a broad range of pathogenic oxidative chemistries that develop in diabetic patients - reducing their numbers and potential for causing irreversible kidney damage.

A TQT study is a specialized clinical trial designed to assess whether an investigational drug has the potential to prolong the QT interval. Note that a prolonged QT interval increases the risk of sudden cardiac death and arrhythmias.

In the cardiac safety study, Pyridorin showed no effect on the QT/QTc interval at the expected therapeutic dose of 300 mg and at a higher dose of 1200 mg.

The phase III program of Pyridorin, in oral formulation, is known as PIONEER, and is designed to include two identical double-blind placebo controlled phase III trials, each of which will enroll about 600 patients.

The company initiated the first of the two studies in the PIONEER program for oral Pyridorin in June of this year. The trial will 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.

Also in the pipeline is intravenous Pyridorin. The company has completed a preclinical study of intravenous Pyridorin for ischemic reperfusion induced acute kidney injury, demonstrating a substantial reduction in the level of renal injury. In the U.S., it is estimated that about 7% of patients in the hospital and as high as 20% - 40% of patients in critical care, develop acute kidney injury.

We alerted our readers to NRX on October 1, 2014 when it was trading around $4.39. The stock closed yesterday's trading at $4.65, down 1.90%. In extended trading, the stock gained 118.28% and was at $10.15.

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