NephroGenex Announces FDA Clearance Of IND Application For Clinical Study Of Intravenous Pyridorin In The Treatment Of Acute Kidney Injury

RALEIGH, N.C.--(BUSINESS WIRE)--NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug (IND) application for clinical studies with intravenous Pyridorin^® for the treatment of acute kidney injury.

“The clearance of our IND application for I.V. Pyridorin represents a significant milestone for our AKI program”

Acute kidney injury (AKI) is a serious medical condition characterized by an abrupt loss of kidney function. AKI is estimated to affect up to 18 percent of hospital inpatients and is responsible for approximately 2 million deaths annually worldwide.^{1, 2} In Company sponsored preclinical studies, I.V. Pyridorin ameliorated renal oxidative stress and injury, enhanced functional recovery and reduced post-injury fibrosis. Additionally, a recently completed preclinical toxicity study of intravenous Pyridorin did not show signs of toxicity or intolerance to the drug.

“The clearance of our IND application for I.V. Pyridorin represents a significant milestone for our AKI program,” said Dr. Jaikrishna Patel, Chief Medical Officer. “We look forward to further investigating intravenous Pyridorin, which we believe has the potential to be an important treatment option for patients suffering from hospital-acquired AKI.”

About Acute Kidney Injury

Acute kidney injury (AKI) is a serious medical condition and significant cause of morbidity, extended hospitalizations and increased medical costs. AKI is characterized by an abrupt loss of kidney function that usually develops within a few hours to a few days, and occurs when the kidneys suddenly become unable to filter water and waste products from the body. AKI is most common in patients who have been hospitalized for other critical conditions or in patients who require surgery. Major causes of hospital-acquired AKI include decreased renal perfusion during surgery, contrast nephropathy and cancer therapy with nephrotoxic drugs such as cisplatin.

About Pyridorin^®

Pyridorin is an investigational compound with a distinct chemical structure that inhibits the formation of advanced glycation end-products (AGEs). 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.

1. Lewington AJP, Certa J, Mehta RL Raising Awareness of Acute Kidney Injury: A Global Perspective of a Silent Killer. Kidney Int. 2013;84(3):457-467

2. Chawla L, Kimmel P. Acute Kidney Injury and Chronic Kidney Disease. Kidney Int. 2012;82(5):516-524.