inflammatory diseases

Diabetic nephropathy is the progressive destruction of the kidneys, one of the most frequent complications of chronic diabetes mellitus and the leading cause for dialysis in the Western world. The disease is characterized by diffuse glomerulosclerosis, the hardening of glomeruli in the kidney, and proteinuria, the leaking of protein from the blood into the urine.
NOX-E36 is a picomolar inhibitor of the chemokine MCP-1, which has been implicated in a variety of inflammatory diseases including nephritis.  The compound was shown to have beneficial effects in animal models of diabetic nephropathy, lupus nephritis and COPD. In the mouse nephropathy model, NOX-E36 significantly improved kidney morphology and/or function as assessed by the rate of glomerular filtration. In June of 2009 NOXXON initiated phase I clinical testing of NOX-E36 in healthy volunteers. In October of 2009 NOXXON reported preliminary phase I trial results demonstrating excellent safety and pharmacokinetic profiles for NOX-E36 in healthy volunteers. In addition, the pharmacodynamic evaluation revealed a dose-dependent decrease of peripheral blood monocytes, consistent with the mode of action of NOX-E36.
The results of this phase I study will be instrumental in the design of the upcoming multiple dose studies in healthy volunteers and non-insulin dependent diabetic patients with multiple complications. The recruitment phase for these studies will begin in early 2010.

Lupus nephritis is a very common renal complication in patients with the autoimmune disease systemic lupus erythematosus, characterized by glomerular inflammation and destruction of the kidney leading to impairment of renal function. Successful treatment is lacking; standard therapy involves administration of powerful corticosteroids and cytotoxic agents like cyclophosphamide.
NOX-E36 has been shown to have beneficial effects in an animal model of lupus nephritis.

Clinical Trial Information:
SNOXE36C001 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects. Further information about this clinical trial is available at ClinicalTrials.gov/show/NCT00976729.

NOX-D14 is highly specific and potent inhibitor of C5a.