NephroGenex Announces Independent DSMB Recommendation to Continue Phase 3 Study of Oral Pyridorin in Diabetic Nephropathy Without Modification

RALEIGH, N.C.--()--NephroGenex, Inc. (Nasdaq: NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company’s pivotal Phase 3 study of oral Pyridorin® for the treatment of diabetic nephropathy has completed the second, pre-planned six-month safety review and has unanimously recommended that the study continue without modification. Based on this review, the DSMB observed a continued acceptable safety and tolerability profile of Pyridorin in patients with overt diabetic nephropathy.

“We are encouraged by the recommendation of the independent DSMB review”

“We are encouraged by the recommendation of the independent DSMB review,” said Pierre Legault, CEO and President of NephroGenex. “We are excited by the progress of our Phase 3 trial, and the potential for Pyridorin to be an important therapy for diabetic nephropathy, a progressive disease for which there are limited treatment options.”

PYR-311 is the first of two double-blind, placebo-controlled studies to evaluate the safety and efficacy of oral Pyridorin, a first-in-class compound for reducing the rate of renal disease progression in type 2 diabetic patients. The trial is being conducted under a Special Protocol Assessment (SPA) from the FDA and has also been granted Fast Track designation.

A DSMB is a committee of independent clinical research experts who review data in ongoing clinical trials with particular attention to safety. As per the study protocol, the DSMB meets every six months to examine the safety data accumulated during progress of the trial.

About Diabetic Nephropathy

Diabetic nephropathy (DN) is a leading cause of end-stage kidney disease. In the Unites States there are approximately 22 million diabetic patients, 40% of whom exhibit signs of DN. Clinically, DN is characterized by a progressive increase of protein in the urine, decrease in the glomerular filtration rate, increase in serum creatinine and ultimately End-Stage Renal Disease (ESRD) requiring dialysis or a kidney transplant. Although optimal control of blood pressure and metabolic risk factors is important in decreasing the progression of diabetic nephropathy, many diabetic patients still develop overt nephropathy and reach ESRD.

About Pyridorin®

Pyridorin is an investigational compound with a distinct chemical structure that inhibits the formation of advanced glycation end-products (AGE). AGEs have been implicated in the development of diabetic nephropathy. In people with diabetes, elevated glucose reacts with proteins to form complexes that are then deposited within the kidney leading to damage that interferes with normal kidney function. AGEs also lead to the generation of highly reactive molecules such as carbonyls and reactive oxygen species that can damage both the outside of the cell and important structures within the cell.

About NephroGenex, Inc.

NephroGenex (Nasdaq: NRX) is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases. Since our inception, we have collaborated with the leading scientific experts to build a portfolio of intellectual property and novel drug candidates. Our clinical program has been designed and implemented in collaboration with world leading clinical investigators in kidney disease. Our product pipeline includes an oral formulation of Pyridorin, 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 acute kidney injury.

Cautionary Note on Forward-Looking Statements

This press release contains certain statements that are, or may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "will," or words of similar meaning and include, but are not limited to, statements regarding the outlook for our future business and financial performance. Forward-looking statements are based on our current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may differ materially from those in the forward-looking statements due to global political, economic, business, competitive, market, regulatory and other factors and risks, including the items identified in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2015, and the “Risk Factors” sections of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2015, June 30, 2015 and September 30, 2015 filed with the SEC on May 13, 2015, August 12, 2015 and November 12, 2015, respectively, as well as in other filings that we may make with the SEC in the future. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements.

Contacts

Investors
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Michael Levitan, 646-378-2920
mlevitan@troutgroup.com
or
Media
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Amy Bonanno, 646-513-3117
abonanno@bmccommunications.com

NephroGenex, Inc.