NephroGenex Reaches Agreement with the FDA on a Subpart H Phase 3 Program for Pyridorin(TM)
Published: Nov 09, 2011
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 treatment to slow the progression of diabetic kidney disease. Pyridorin is one of only a few drug candidates in advanced clinical trials for diabetic kidney disease, and possesses a distinctly new mechanism of action which targets an important diabetes-induced underlying cause of the disease.
SOURCE NephroGenex, Inc.