RESEARCH TRIANGLE PARK, N.C., Nov. 7, 2011 /PRNewswire/ -- NephroGenex, Inc., a privately held drug development company, today announced the completion of PYR-210, a Phase 2b trial that studied the safety and efficacy of its lead drug candidate Pyridorin™ (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt nephropathy.
PYR-210 evaluated two doses of Pyridorin™ against placebo in 317 patients over a one year treatment period. Patients enrolled in the trial were type 2 diabetic patients with elevated serum creatinine (SCr) levels and significant proteinuria, and were on standard of care which included adequate blood pressure control and a stable regimen of ACEi/ARB therapy. Efficacy was evaluated based on a 12 month change in SCr from baseline.
As reported in the current online issue of the Journal of the American Society of Nephrology, Pyridorin™ was well tolerated and has a benign safety profile. Pyridorin™ did not produce a significant treatment effect in the entire patient population treated; however, in patients with less severe disease (i.e. baseline SCr values less than 1.9 mg/dL), Pyridorin™ did produce a treatment effect greater than 50% relative to placebo that is statistically significant.
Patients treated with Pyridorin™ who were on previously established standard of care at screening, with a baseline SCr of up to 3 mg/dL, which includes patients with both mild and moderate levels of disease, showed a highly significant 57% treatment effect for the 300 mg arm (P = 0.009; n=64) and 45% for the 150 mg arm (P=0.045; n=62) relative to placebo. Pyridorin also slowed the progression of cystatin C and caused a reduction in urinary TGF beta in this patient population.
Approximately 70 to 80% of diabetic overt nephropathy patients have SCr values less than 2 mg/dL and approximately 80 to 90% have SCr values less than 3 mg/dL. Thus, Pyridorin™ therapy has demonstrated efficacy in the large majority of diabetic patients with overt nephropathy.
In two previous Phase 2a trials, Pyridorin™ therapy demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy as measured by the change in serum creatinine over a six month treatment period. Pyridorin therapy also demonstrated a reduction in urinary TGF beta, an important marker of glomerulosclerosis and tubulointerstitial fibrogenesis.
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.|
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