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GKT137831 is a selective NOX1/4 inhibitor in Phase II clinical development for the treatment of diabetic nephropathy, one of the complications of diabetes. It is a potent, NOX specific, small molecule with good oral availability.
Data from the Phase 1 programme to assess safety and exposure to single and multiple oral doses of GKT137831 was presented at the ASN Kidney week in San Diego in 2012. More than 100 subjects have been exposed to GKT137831 and the drug was well tolerated with no serious adverse events. In summer 2013, the FDA approved the IND to allow commencement of the Ph2 PoC trial of GKT137831 in diabetic nephropathy. Subsequently, approvals have been received from the competent authorities in Australia, Canada, Germany, Czech Republic and Poland. Enrollment to this study is ongoing and data is expected in H1 2015.
GKT137831 has been found to be effective in a range of preclinical disease models. This work has been conducted by leading academic collaborators in disease models of diabetic nephropathy, atherosclerosis, idiopathic pulmonary fibrosis, liver fibrosis and angiogenesis. GKT137831 has therefore, the potential to treat a wide range of important and poorly managed diseases.