NephroGenex initiates patient enrollment in first Pyridorin Phase III trial

The trial is designed to assess the safety and efficacy of Pyridorin in slowing disease progression in patients with diabetic nephropathy.

NephroGenex CEO Pierre Legault said with the start of this study, the company is now in late stage development with a first-in-class compound that targets and scavenges pathogenic oxidative chemistries which are fundamental causative factors in the development and progression of diabetic nephropathy.

"Of the 19 million people in the U.S. diagnosed with diabetes, about one third-or roughly 6 million people-exhibit signs and symptoms of kidney disease," Legault said.

"Pyridorin is the leading drug candidate for diabetic nephropathy that targets an underlying cause of this disease."

The PIONEER program will include two identical double-blind placebo controlled Phase III trials, each is designed to assess the safety and efficacy of Pyridorin at 300mg twice a day compared to placebo in reducing the rate of renal disease progression in type 2 diabetic patients.

About 600 patients will be enrolled in each trial and they will be randomized in a 1:1 ratio to receive either Pyridorin or placebo.

Around 100 centers will participate worldwide in the trial, with the majority being located in the US.

The trial’s primary efficacy endpoints are time to a 50% increase in serum creatinine (SCr) levels, or end stage renal disease (ESRD).

The company has reached agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the PIONEER clinical program, and also secured FDA fast track status for Pyridorin in diabetic nephropathy.

Image: NephroGenex’s Phase III trial is designed to evaluate the safety and efficacy of Pyridorin at 300mg twice a day compared to placebo.Photo: courtesy of Vichaya Kiatying-Angsulee/ freedigitalphotos.net