NOXXON Pharma AG announced today that it has permission to commence a multiple ascending dose study of its Monocyte Chemoattractant Protein-1 (MCP-1) targeting anti-inflammatory Spiegelmer®, NOX-E36. NOXXON plans to develop NOX-E36 for the treatment of diabetic nephropathy and other diabetes related complications.
The double-blind, placebo controlled, Phase I study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the MCP-1 inhibitor NOX-E36 in four groups of subjects. The first group, composed of healthy volunteers, will receive NOX-E36 i.v. every other day for 15 days. The three remaining groups, composed of type II diabetic patients, will receive ascending doses of NOX-E36 i.v. every other day for 27 days.
Dr Frank Morich, CEO of NOXXON Pharma AG, commented: "The pharmacokinetic and pharmacodynamic data from diabetic patients who will be enrolled in this NOX-E36 study will guide NOXXON in choosing the doses and endpoints most likely to reveal the therapeutic potential of NOX-E36 in a Phase II program. Given the absence of existing therapies in the indications targeted by NOX-E36 the inclusion of diabetic patients is a crucial step in defining the best path forward."
The NOX-E36 multiple ascending dose study is scheduled to begin treatment of the first group of subjects in August 2010. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01085292).