NephroGenex, Inc.’s (NRX) shares surged significantly to reach a 52-week high of $17.98 per share after the company announced that its lead candidate, Pyridorin, was found safe in a cardiac safety study (thorough QT/QTc (TQT) analysis).
Pyridorin is currently being evaluated in a phase III program as a chronic, therapeutic agent to slow the progression of diabetic nephropathy. An intravenous formulation of Pyridorin is also under development for the treatment of specific types of acute kidney injury.
The QT/QTc (TQT) study, which is a standard component of all clinical development programs for new molecular entities, was conducted to assess the proarrhythmic potential of Pyridorin and the risk associated with its QT prolongation. NephroGenex said that two doses of Pyridorin, 300 mg and 1200 mg, did not show any effect on the QT/QTc interval. This result was consistent with results of the QT/QTc analysis conducted during the phase I and phase II studies on the candidate.
According to the company, results obtained from the cardiac safety study on Pyridorin will support the development of Pyridorin for the treatment of diabetic nephropathy patients suffering from cardiovascular disease. NephroGenex’s estimates show that almost six million patients in the U.S. currently suffer from diabetic nephropathy, which constitutes roughly 33% of the diagnosed diabetic population. The company expects this patient population to grow in future. According to NephroGenex, adequate treatments have not yet been approved for this disease.
We note that Bristol-Myers Squibb (BMY)/Sanofi’s (SNY) Avapro (irbesartan) is approved for the treatment of diabetic nephropathy in type II diabetes patients suffering from hypertension.
Meanwhile, NephroGenex continues to work on the development of Pyridorin for the treatment of diabetic nephropathy in patients with type II diabetes as well as other indications.
Investors looking for well ranked stocks in the health care may consider Lannett Company, Inc. (LCI) carrying a Zacks Rank #1 (Strong Buy).
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