NephroGenex Inc. completed 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.
The study 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.
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), the drug 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 and 45% for the 150 mg arm relative to placebo.
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.
Release Date: November 7, 2011
Source: NephroGenex Inc.