NephroGenex, Inc., a pharmaceutical company focused on the development of therapeutics to treat kidney disease, announced that the US 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.

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 per cent of hospital inpatients and is responsible for approximately 2 million deaths annually worldwide. 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.

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.

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