NOXXON Pharma today announced the successful completion of patient recruitment of its NOX-E36 Phase IIa clinical trial for the treatment of diabetic nephropathy. NOX-E36 is a Spiegelmer® that binds and neutralizes CCL2/MCP-1 (C-C Chemokine Ligand / Monocyte Chemoattractant Protein-1), a pro-inflammatory chemokine that plays an important role in the progression of diabetic nephropathy, the most common single cause of chronic kidney failure and end-stage renal disease.
The objective of this randomized, double-blind placebo-controlled Phase IIa study is to evaluate the efficacy, pharmacokinetics, safety and tolerability of treatment with NOX-E36. It has now enrolled the targeted 75 patients with type 2 diabetes mellitus and albuminuria who will be treated for 12 weeks with twice-weekly subcutaneous doses of NOX-E36 (50 patients) or placebo (25 patients). All patients are also treated with the current standard of care to control hypertension, hyperglycemia and dyslipidemia. This regimen includes stable renin-angiotensin system blockade, which has been demonstrated in randomized controlled trials to reduce the rate of progression of diabetic nephropathy in type 2 diabetics with hypertension, elevated serum creatinine and albuminuria.
The planned interim efficacy analysis of the first third of patients completing therapy in this Phase IIa study has now been completed with promising results. The primary efficacy analysis is based on the change in albuminuria from baseline at the end of the treatment period, expressed as albumin to creatinine ratio (ACR). Further analyses of efficacy parameters will occur following treatment of 51 and 75 patients. In addition to renal parameters, glycemic and inflammatory markers are being followed during the trial.
Dr. Matthias Baumann, Chief Medical Officer of NOXXON Pharma remarked: "We are very pleased with the excellent safety and tolerability seen so far in the study. Recently increased patient recruitment will allow efficacy analysis of all 75 patients later this year and full analysis of the study in early 2014. We plan to present interim results at one of the upcoming major international scientific conferences."