Genkyotex announces initiation of GKT137831 Phase II study in patients with diabetic nephropathy

Nov 5 2013

Genkyotex, the leading developer of selective NOX enzyme inhibitors, announced today the initiation of 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.

"There is a significant need for more effective therapies for diabetic nephropathy, particularly as the prevalence of this disease continues to rise. The central role of NOX enzymes in diabetic kidney disease suggests that GKT137831 may confer broad therapeutic benefits to patients," explained Dr. Kumar Sharma, Professor of Medicine, Director, Institute of Metabolomic Medicine and Director, Center for Renal Translational Medicine, University of California, San Diego. "Studies to date in preclinical models of the disease have shown very promising results and we look forward to seeing data from diabetic patients."

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.

"This is the first targeted NOX inhibitor to be trialled in patients and the study will provide extensive data about the role of NOX and NOX inhibition in this group of patients with nephropathy,'' said Dr. Philippe Wiesel, Genkyotex's Chief Medical Officer. "Investigational sites are now being opened in North America and the study will be rolled out to centres in Europe and Australia as well. We look forward to reporting on data in the first half of 2015.''

An oral presentation entitled "Genetic Deletion And Pharmacological Inhibition Of The NADPH Oxidase NOX4 Provides Renoprotection In Diabetes-Induced Nephropathy" will be given on November 9 at 4:54 pm in Room 308 during the American Society of Nephrology's Kidney Week 2013 Annual Meeting (November 7-10, Atlanta, GA). The presentation with be given by Dr. Jay Jha of the Baker IDI Heart & Diabetes Institute, Melbourne and will include data showing the positive effects of GKT137831 administration in models of diabetic nephropathy.