RESEARCH TRIANGLE PARK, N.C., Nov. 7, 2011 /PRNewswire/ -- NephroGenex, Inc., a privately held drug development company, today announced that it has reached an agreement with the FDA on the design of a new Phase 3 Subpart H program that evaluates Pyridorin™ in diabetic nephropathy patients. This Subpart H program uses a novel surrogate endpoint based on an increase in serum creatinine (SCr), and provides for an accelerated regulatory pathway to approval.
The new surrogate endpoint was determined from a comprehensive analysis of prior large clinical trials in diabetic nephropathy patients that demonstrated a highly significant relationship between increases in SCr and the future progression of patients to end stage renal disease (ESRD).
In the Pyridorin™ Phase 3 Subpart H program, the FDA has agreed that approval will be based on a new surrogate endpoint that includes SCr changes after one year that predict progression to ESRD. These patients will subsequently be followed to confirm the clinical benefit of Pyridorin™ in delaying progression to ESRD. The patient population for the study will be type 2 diabetic patients with overt nephropathy who are on an established standard of care consisting of adequate blood pressure control and a stable regimen of ACEi/ARB therapy.
Diabetic kidney disease afflicts approximately one-third of all diabetics and is the major cause of ESRD, which is a significant component of healthcare expenditures. Mortality rates for ESRD patients can reach 20% annually. Pyridorin™ has been awarded Fast Track status by the FDA due to the unmet medical need of patients with this life-threatening disease.
About NephroGenex, Inc.
NephroGenex (www.nephrogenex.com) is a drug development company focusing on kidney disease. The Company is developing Pyridorin™ (pyridoxamine dihydrochloride) as a treatme
|SOURCE NephroGenex, Inc.|
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