NOXXON Pharma announced the treatment of the first patient in a Phase 2a clinical trial of its anti-CCL2/MCP-1 (C-C Chemokine Ligand 2 or Monocyte Chemoattractant Protein-1) Spiegelmer NOX-E36 in patients with diabetic nephropathy. About 1 in 3 patients with diabetes mellitus develops diabetic nephropathy, a progressive kidney disease that is one of the main causes of end-stage renal disease and the need for dialysis. The recruitment of immune cells by the chemokine CCL2 into the kidney along with direct effects of CCL2 on cells of the kidney are believed to be important in the progression of this disease.
NOXXON Pharma’s multi-center, double-blind study will be conducted on 75 patients with Type II diabetes mellitus and albuminuria with a treatment duration of 12 weeks. 50 patients will be administered subcutaneous doses of 0.5 mg/kg of NOX-E36 twice weekly and the remaining 25 patients will receive placebo. The dose choice of 0.5 mg/kg of NOX-E36 is based on data from an earlier Phase Ib study which evaluated the pharmacodynamic effects of three different doses of NOX-E36 in diabetics during four weeks of treatment. All patients in the Phase 2a study will also be on the current standard of care to control hypertension, hyperglycemia and dyslipidemia.
The study will evaluate efficacy, PK, safety and tolerability of treatment with NOX-E36. The primary efficacy analysis will be based on a change from baseline in the albumin to creatinine ratio (ACR); renal, glycemic and inflammatory efficacy markers will also be followed during the trial. Interim evaluation of primary and secondary efficacy parameters is planned following completion of treatment of 25, 50 and 75 patients.
NOX-E36’s mode of action is to specifically bind and neutralize the pro-inflammatory chemokine CCL2/MCP-1. This protein recruits immune cells to sites of inflammation and it plays an important role in complications of type 2 diabetes through recruitment of immune cells to adipose tissue, pancreatic islets and the kidney. CCL2 also triggers down-regulation of the protein nephrin, a key component of the renal filtration apparatus expressed by the kidney’s podocyte cells. Inhibition of CCL2 is thus anticipated to be of benefit for type 2 diabetes patients with nephropathy. Preclinical studies have demonstrated that treatment with a Spiegelmer CCL2 inhibitor can significantly delay the decline in kidney function as well as disease progression in animal models of diabetes.
This Phase 2a study is the fourth clinical study of NOX-E36 that NOXXON Pharma has initiated and the Company is building up a positive bank of data supporting this product’s potential in treating subjects with renal impairment. NOXXON plans to provide interim results from this trial later this year.
Date: June 19, 2012
Source: NOXXON Pharma AG
