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Trials & Filings

Genkyotex Begins NOX Inhibitor Trial

Tests against diabetic nephropathy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Genkyotex has begun a multinational Phase II clinical study of GKT137831 in patients with diabetic nephropathy. GKT137831 is a first-in-class inhibitor targeting NOX1 and NOX4 enzymes, both of which play a key role in the development of diabetic complications and chronic kidney disease in particular. In Phase I studies in more than 100 subjects, GKT137831 was found to be safe and well tolerated when administered orally once and twice daily.

The placebo controlled, double-blind, randomized Phase II clinical study has been designed to evaluate the safety and efficacy of GKT137831 in 120 patients with Type 2 diabetes and residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system. The primary endpoint of the study is the change in the urine albumin-to-creatinine ratio (UACR) versus baseline. Secondary endpoints include changes in markers of glucose metabolism, adipose tissue dysfunction and inflammation, and in predictive markers of progression to end-stage renal disease. The company hopes to report on data from the trial in the first half of 2015.

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