Patient enrollment completed in Phase 2b clinical trial for Pyridorin

Sep 10 2009

NephroGenex, Inc., a privately held drug development company focusing on kidney disease, today announced the completion of patient enrollment in its Phase 2b clinical trial (PYR-210) studying the safety and efficacy of its lead drug candidate Pyridorin(TM) (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy. Three hundred and seventeen (317) patients have been randomized.

The study is being conducted by the Collaborative Study Group (CSG) at approximately 65 sites in the United States, Australia and Israel. The CSG is a site management organization of nephrologists that has conducted notable landmark studies in diabetic nephropathy in the past, including studies leading to approval of drugs for this indication.

The trial is evaluating two doses of Pyridorin(TM) against placebo in approximately 300 patients for a one year treatment period. Recruited type 2 diabetic patients have elevated serum creatinine levels and significant proteinuria. The estimated study completion date is August 2010. Further details of PYR-210 are available at clinicaltrials.gov (Identifier NCT00734253). The trial is incorporating the latest discussion with the FDA regarding the use of an approvable surrogate endpoint that would be subsequently confirmed with hard clinical endpoints.

In previous Phase 2a trials, Pyridorin(TM) therapy demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy as measured by the change in serum creatinine and serum cystatin C over six months, as well as a reduction in urine TGF-beta.

Diabetic kidney disease afflicts about 20% of all diabetics and is the major cause of end-stage renal disease (ESRD) which is an enormous drain on healthcare expenditures. Mortality rates of ESRD patients can reach 20% annually. Pyridorin(TM) has been awarded Fast Track status by the FDA due to the unmet medical need of this life-threatening disease.