Biopharmaceutical company NOXXON Pharma has completed patient recruitment for Phase IIa study of NOX-E36, a Spiegelmer that binds and neutralises C-C Chemokine Ligand / Monocyte Chemoattractant Protein-1 (CCL2/MCP-1), to treat diabetic nephropathy.
CCL2/MCP-1 is a pro-inflammatory chemokine believed to play a vital role in the progression of diabetic nephropathy.
NOXXON Pharma chief medical officer Dr Matthias Baumann said: "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."
Designed to assess the efficacy, pharmacokinetics, safety and tolerability of treatment with NOX-E36, the randomised, double-blind study enrolled the targeted 75 patients with type 2 diabetes mellitus and albuminuria.
The placebo-controlled study will treat the patients with twice-weekly subcutaneous doses of NOX-E36 (50 patients) or placebo (25 patients) for a 12-week period along with the current standard of care to control hypertension, hyperglycemia and dyslipidemia.
The regimen includes stable renin-angiotensin system blockade that demonstrated to reduce the rate of progression of diabetic nephropathy in type 2 diabetics with hypertension, elevated serum creatinine and albuminuria in randomised controlled trials.
The planned interim efficacy analysis of the first third of patients completing therapy in the study demonstrated promising results where 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), according to the company.
Further efficacy parameters will be analysed following treatment of 51 and 75 patients.
During the trial, glycemic and inflammatory markers are being followed besides renal parameters.
Image: Nodular glomerulosclerosis in the kidney of a patient with diabetic nephropathy. US Federal Government public domain image. Photo: courtesy of CDC.