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news.US biotech company NephroGenex has acquired rights to the investigational drug Pyridorin for the treatment of diabetic nephropathy and acute renal failure.
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The company licensed the rights to commercialize the drug in diabetic neuropathy from North Carolina-based Biostratum, while it acquired the commercial rights to the drug in acute renal failure from Vanderbilt University. Financial details for either of the deals have not been made public.
In diabetic neuropathy, Pyridorin has been evaluated in two phase II clinical trials demonstrating in both a significant treatment effect in stemming the progression of the disorder.
According to the company, developing treatments for diabetic nephropathy is problematic because of significant patient variability in the progression of the disease. As a result, adequate powering of phase III trials necessitates large patient populations and long treatment periods. This has been a major obstacle in the development of therapies for this debilitating and costly disease.
Recent advances in molecular urinalysis have determined biomarkers that can identify with a high level of accuracy diabetic patients with nephropathy. NephroGenex is expanding on these advances to identify diabetic nephropathy ‘progressors’ for recruitment into phase III clinical trials.
By removing ‘non-progressors’ from the trial, the prospects for demonstrating a significant treatment effect are dramatically improved.