NephroGenex Announces Successful Results from Toxicity Study of Intravenous Pyridorin

No signs of intolerance or toxicity at high doses

RALEIGH, N.C.--()--NephroGenex, Inc. (Nasdaq: NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced successful results from a preclinical toxicity study of intravenous Pyridorin® being developed to treat acute kidney injury (AKI). Male and female Sprague-Dawley rats given 50, 100 and 200 mg/kg of Pyridorin (Pyridoxamine Dihydrochloride) once daily by intravenous infusion over 30 minutes for seven consecutive days, were free of any clinical signs of intolerance or toxicity to the drug. Key parameters evaluated included clinical signs, functional observational battery tests, body weight, food consumption, hematological parameters, serum chemistry and urinalysis parameters, gross necropsy findings, and histology.

The study also showed that there were no Pyridorin-related gross or microscopic findings in the nervous system (brain, spinal cord, spinal nerve roots/ganglia, and peripheral nerves). These findings add to the body of evidence that has demonstrated a consistent absence of treatment-emergent neuropathy in non-clinical and clinical studies with Pyridorin. This is in contrast with structurally distinct pyridoxine that has been associated with neurotoxicity in preclinical studies and in reports of patients taking mega-doses (2-5 g/day) for prolonged period ranging from 2-40 months.

“The results of this intravenous Pyridorin study will be used to support an IND filing, anticipated for later this year, of I.V. Pyridorin for the treatment of acute kidney injury,” commented Dr. Jaikrishna Patel, Chief Medical Officer.

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 and June 30, 2015 filed with the SEC on May 13, 2015 and August 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:
The Trout Group
Michael Levitan, 646-378-2920
mlevitan@troutgroup.com
or
Media:
BMC Communications
Amy Bonanno, 646-513-3117
abonanno@bmccommunications.com

Contacts

Investors:
The Trout Group
Michael Levitan, 646-378-2920
mlevitan@troutgroup.com
or
Media:
BMC Communications
Amy Bonanno, 646-513-3117
abonanno@bmccommunications.com