NOXXON Announces Initiation of First Clinical Trial with a Spiegelmer®

Berlin, (PresseBox) - NOXXON Pharma AG (NOXXON) announced today the successful initial dosing of healthy volunteers with Spiegelmer® NOX-E36 in the company's first-in-human clinical trial. The Phase I program is currently underway in the United Kingdom following review and approval of the Clinical Trial Application by the Medicines and Health product Regulatory Authority (MHRA). The study will evaluate the tolerability, safety and pharmacokinetics in up to 72 individuals following intravenous and subcutaneous administration of anti-inflammatory Spiegelmer ® NOX-E36. The results obtained in the Phase I trial will guide the Phase II program to be conducted in patients suffering from nephropathy.

"With the initiation of this Phase I study, Spiegelmers® have reached the next level of maturity", commented Dr. Frank Morich, Chief Executive Officer of NOXXON. "This event marks NOXXON's transition to a clinical-stage company and represents a major milestone in our continued effort to develop a pipeline of a novel and innovative class of pharmaceuticals to address major medical needs."

Spiegelmer® (L-aptamers) are chemical entities based on synthetic mirror-image oligonucleotides. Thanks to their unique mirror image configuration Spiegelmers® are not metabolized and do not hybridize with native nucleic acids. Spiegelmers® also do not activate the innate immune response via Toll-like receptors and have shown an exceptionally favorable immunogenicity profile in pre-clinical testing.

NOXXON's lead compound NOX-E36 is a new therapeutic modality that specifically targets the pro-inflammatory chemokine Monocyte Chemotactic Protein-1 (MCP-1, also known as CCL2). Previously completed experiments in various animal models of kidney disease demonstrate that treatment with Spiegelmer® MCP-1 antagonists significantly delays the decline in kidney function as well as disease progression. NOXXON is planning to develop NOX-E36 for the treatment of inflammatory kidney diseases including diabetic nephropathy. Diabetic nephropathy is a growing public health threat due to the high and continually growing incidence of type II diabetes. Approximately thirty percent of patients diagnosed with diabetes develop nephropathy; twenty percent of these patients suffer from end stage renal disease. Diabetic nephropathy is the leading cause for chronic kideny disease and dialysis treatment in the Western world.

Noxxon Pharma AG

Berlin-based NOXXON Pharma AG is a clinical stage biotechnology company focusing on the development of Spiegelmers® for the treatment of inflammatory diseases and hematological indications. In addition to its in-house programs NOXXON discovers and develops Spiegelmers® in collaboration with partners from the pharmaceutical industry, including Eli Lilly, Hoffmann La-Roche and Pfizer. Spiegelmers ® (the German word "Spiegel" means mirror) are chemical entities based on synthetic L-nucleic acids. They are highly selective for their pharmacological target and potent inhibitors of target function. The substance class exhibits exceptional metabolic stability and an outstanding immunogenicity profile - a new generation of improved therapeutics.

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