RESEARCH TRIANGLE PARK, -- NephroGenex, Inc., a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced collaborations with two leading research organizations to conduct the Company's Phase 3 PIONEER (PyrIdOriN in DiabEtic NEphRopathy) study.
The Company has partnered with the Collaborative Study Group (CSG), a world leading nephrology academic research organization with 300 affiliated clinics worldwide, and Medpace, a contract research organization with demonstrated expertise and experience in nephrology. The firms will collaborate with NephroGenex to conduct the Pyridorin Phase 3 PIONEER study. The Company expects to launch the first of two Phase 3 trials in the first half of 2014.
"We are pleased to have onboard the capabilities of CSG and Medpace as we launch our late-stage program in diabetic kidney disease," commented Chief Executive Officer Pierre Legault. "Both organizations were instrumental in conducting our previous Phase 2b study, through which we were able to identify a Phase 3 patient population accepted by the FDA under a Special Protocol Assessment. These collaborations give NephroGenex the reach and expertise required to successfully execute the oral Pyridorin Phase 3 PIONEER program through to regulatory submission."
The Pyridorin Special Protocol Assessment (SPA) includes a novel, fully approvable endpoint (50% serum creatinine increase versus 100%) that will reduce by approximately half the patient follow-up time and cost. The SPA also allows for a patient population where Pyridorin previously demonstrated greater than a 50% treatment effect in the Phase 2 studies.
Pyridorin inhibits pathogenic oxidative chemistries which are collectively a group of oxygen-based chemical reactions that are elevated in diabetic patients and induce pathological changes in tissues including blood vessels and the kidney. These chemistries have been implicated in the development of diabetic nephropathy. Pyridorin inhibits a broad range of these chemistries which we believe accounts for its effectiveness in slowing the progression of nephropathy in diabetic patients as shown in our Phase 2 studies.
About Diabetic Nephropathy
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 or death. There are currently no adequate treatments for this disease.
About NephroGenex, Inc.
NephroGenex is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Since our inception, we have collaborated with the leading scientific experts in pathogenic oxidative chemistries to build a strong portfolio of intellectual property and novel acting drug candidates. Our clinical program has been done in collaboration with world leading clinical investigators in kidney disease. Our product pipeline includes an oral formulation of Pyridorin(TM), which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat specific types of acute kidney injury.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in the prospectus related to the initial public offering, and in other filings that NephroGenex may make with the SEC in the future. The forward-looking statements contained in this press release reflect NephroGenex's current views with respect to future events, and NephroGenex does not undertake and specifically disclaims any obligation to update any forward-looking statements.