NephroGenex - Innovative Therapies for Kidney Disease
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PyridorinDiabetic NephropathyOther IndicationsPublished Articles on Pyridorin


Pyridorin™

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

Pyridorin™ Fast Facts:
  • Name - Pyridorin™ (pyridoxamine dihydrochloride)
  • History - Rights acquired from BioStratum
  • Active Ingredient - Pyridoxamine dihydrochloride
  • Target - Intercepting and preventing pathogenic oxidative chemistries
  • Indication - Kidney disease in patients with type 2 diabetes
  • Status - Completed three phase 2 clinical trials demonstrating safety and a promising treatment effect; Phase 3 subpart H program with new surrogate endpoint for approval
  • Market Potential - approximately 2.8 M patients with overt diabetic nephropathy in the U.S; approximately 3.5 M have earlier microalbuminuria
  • Commercialization - NephroGenex will seek a partner for Phase 3 development and commercialization
  • Anticipated Market Entry Date - 2016

Diabetic Nephropathy

Pyridorin™ targets a broad range of pathogenic oxidative chemistries, including advanced glycation end-products, toxic carbonyls, and reactive oxygen species that develop in patients with diabetes and are considered a principal causative factor in the development of diabetic microvascular disease. Hyperglycemia-induced microvascular disease is the fundamental cause of diabetic complications, including nephropathy, retinopathy, and neuropathy.

Pyridorin™ has been evaluated in three Phase 2 clinical trials and in all three trials has demonstrated a significant treatment effect in retarding the progression of diabetic nephropathy. NephroGenex is continuing the clinical study of Pyridorin™ for diabetic overt nephropathy in a Phase 3 Subpart H program that uses a novel surrogate endpoint that provides for an accelerated regulatory pathway to approval.

Other Indications

NephroGenex is also studying the application of Pyridorin™ to specific types of acute renal failure in which pathogenic oxidative chemistries have been identified as likely causative factors in the onset and progression of this condition. These include contrast-dye-induced acute renal failure and ischemia-reperfusion acute renal injury, which can arise in cardiac and vascular surgeries.

 

Nephrogenex, Inc – 79 T.W. Alexander Drive, Building 4401, Suite 290 – P.O. Box 14188 – Research Triangle Park, NC 27709-4188.