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
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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.
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