NephroGenex Announces Data on Acute Kidney Injury at National Kidney Foundation 2015 Spring Clinical Meetings

NephroGenex, Inc. NRX, a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced positive results on preclinical studies that evaluate Pyridorin® as a treatment for acute kidney injury. The data are being presented today at the National Kidney Foundation's 2015 Spring Clinical Meetings. Pyridorin is a novel compound shown to target and reduce pathogenic oxidative chemistries that emerge in kidney disease. Oral Pyridorin is being evaluated in a pivotal Phase 3 program in diabetic nephropathy. In the poster session, "Pyridorin Treatment in Ischemia-Reperfusion Model of AKI," researchers reported on a preclinical model of hospital-acquired acute kidney injury (AKI), a major cause of morbidity, extended hospitalizations and increased medical costs. AKI can occur from a decreased renal reperfusion during surgery, contrast-dye infusion, and anti-cancer therapies. The AKI that results from these procedures is accompanied by an increase in pathogenic oxidative chemistries which likely contributes to the kidney tissue damage and reduced renal function that develops in this indication. Pyridorin scavenges and inhibits pathogenic oxidative chemistries, and therefore could be a promising treatment for AKI. The study showed that treatment with Pyridorin significantly reduced the severity of acute kidney injury in a model of ischemia reperfusion, which emulates the AKI that can result following cardiopulmonary bypass surgery. Mice were administered doses of Pyridorin prior to the surgically-induced AKI. Pyridorin treatment was shown to significantly reduce the level of kidney injury, enhance renal function recovery, and reduce post-injury fibrosis. Treatment with a higher dose of Pyridorin was shown to be even more beneficial. "These are exciting early results with Pyridorin in this important indication," commented Chief Executive Officer Pierre Legault. "We're in discussion with the U.S. FDA regarding design of a clinical program in acute kidney injury, and anticipate initiating an AKI Phase 1 study during second half of 2015." Also at the meeting, the Company presented PIONEER, the ongoing pivotal Phase 3 trial with Pyridorin in diabetic nephropathy. In a poster session, "Design of a Phase 3 Clinical Trial in Type 2 Diabetic Nephropathy with Pyridoxamine dihydrochloride (Pyridorin)," lessons from previous studies in diabetic nephropathy were discussed, along with the use of a novel renal endpoint that is being used as the primary approvable endpoint. A Special Protocol Assessment (SPA) has been granted to this program by the U.S. FDA.