Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.NephroGenex, a pharmaceutical company focused on the development of therapeutics to treat kidney disease, has successfully completed a thorough QT/QTc (TQT) cardiac safety study on Pyridorin.
Subscribe to our email newsletter
This study assesses a drug’s risk of QT prolongation and its proarrhythmic potential, and is a standard component of all clinical development programs for new molecular entities.
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. In previous Phase 1 and Phase 2 studies, Pyridorin has shown no effect on the QT/QTc interval in patients with diabetic nephropathy.
"These are important study results that support the use of Pyridorin in patients with diabetic nephropathy, many of whom suffer from cardiovascular disease. They are also important given the concerns over cardiac safety seen with other therapies in development for this disease," said Chief Executive Officer Pierre Legault.
"The overall excellent safety profile we are continuing to see, along with the promising efficacy shown in our Phase 2 trials, continues to suggest that Pyridorin has the potential to broadly address the unmet therapeutic needs of the more than 6 million diabetic patients with kidney disease."
Diabetic nephropathy is a chronic, degenerative disease of the kidney caused by diabetes. There are approximately 6 million patients with diabetic nephropathy in the United States (approximately 33% of diagnosed diabetics) and this population is expected to grow.
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.