Pyridorin pyridoxamine: Phase IIb data

The double-blind, U.S. Phase IIb PYR-210 trial in 307 evaluable patients showed that twice-daily 150 and 300 mg Pyridorin each missed the primary endpoint of significantly reducing the progressive increase in serum creatinine levels from baseline to 1 year vs. placebo (0.42 and 0.36 mg/dL, respectively, vs. 0.36 mg/dL; p=0.48 and p=0.95, respectively). In patients with less severe disease at baseline (serum creatinine levels of 1.3-1.85 mg/dL), low- and high-dose Pyridorin did significantly reduce the progressive increase in serum creatinine levels from baseline to 1 year vs. placebo (0.7 and 0.14 mg/dL, respectively, vs. 0.28 mg/dL; p=0.046 for both). Pyridorin was well tolerated. The trial enrolled Type II diabetics with elevated serum creatinine levels and proteinuria who were receiving standard of care that included adequate blood pressure control and a stable regimen of angiotensin-converting enzyme (ACE) inhibitor and/or angiotensin-receptor blocker (ARB) therapy. Data were published in the Journal of the American Society of Nephrology. ...