NephroGenex, Inc. NRX, a pharmaceutical company focused on the
development of therapeutics to treat kidney disease, today announced the
Company has successfully completed a thorough QT/QTc (TQT) cardiac safety
study on Pyridorin. 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.”
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