NephroGenex - Innovative Therapies for Kidney Disease
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Overview

NephroGenex's focus is the development of novel therapies for kidney disease. The Company is headquartered in Princeton, New Jersey.

NephroGenex has acquired commercial rights to Pyridorin™ (pyridoxamine dihydrochloride). Pyridorin™ targets diabetes-induced carbonyl and oxidative chemistries that are a principal causative factor in the development of diabetic nephropathy and other diabetic complications.

Pyridorin™ has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in two Phase 2 clinical trials, and has been awarded Fast Track status by the FDA. NephroGenex is conducting a new Phase 2b clinical trial (PYR-210) that is evaluating the safety and efficacy of Pyridorin™ in slowing the progression of overt nephropathy in patients with type 2 diabetes. This trial incorporates the latest discussion with the FDA regarding the use of an approvable surrogate marker that would be subsequently confirmed with hard clinical endpoints. The trial will be completed in September 2010.

Diabetic kidney disease afflicts about 33% of all diabetics and is the major cause of end-stage renal disease (ESRD). There are an estimated 2.8 million diabetic overt nephropathy patients in the US, and approximately 3.5 million diabetic patients exhibiting signs of developing kidney disease. Pyridorin™ is one of only two drug candidates in advanced clinical trials for diabetic kidney disease.

NephroGenex is also studying the application of Pyridorin™ to specific types of acute renal failure where carbonyl and oxidative chemistries have been identified as causative factors in the onset and progression of this condition.

Corporate Objectives

NephroGenex’s principal corporate objective is the acquisition of clinical candidates with application to kidney disease. NephroGenex’s business model leverages the enormous medical need and market opportunity that exist for treatments that can slow the progression of renal disease and thus delay or avoid the onset of end-stage renal disease (ESRD).

NephroGenex acquired commercial rights to Pyridorin™ and is currently investigating the safety and efficacy of Pyridorin™ therapy for diseases in which pathogenic carbonyl and oxidative chemistries are an established causative factor in kidney disease. These include diabetic nephropathy and acute renal injury.

The Company aims to undertake its subsequent evaluation in Phase 2 safety and efficacy trials against relevant patient populations identified using the latest advances in clinical research and kidney-disease diagnostics.

The Company will seek corporate partners for Phase 3 development and commercialization.


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