NOXXON Pharma AG Announces Preliminary Phase I Trial Results for Spiegelmer® NOX-E36
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The phase I study, conducted in the United Kingdom, was performed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the chemokine inhibitor NOX-E36 in 72 healthy volunteers. A double-blind, placebo-controlled, single ascending dose study design was used to investigate escalating intravenous doses, the bioavailability of subcutaneous doses and potential gender differences.
Preliminary results show NOX-E36 to be safe and well tolerated at all dose levels in both the intravenous and subcutaneous groups. NOX-E36 showed dose-linear pharmacokinetics, leading to plasma concentrations well above those known to be effective in animal models.
Pharmacodynamic evaluation indicates a dose-dependent decrease of peripheral blood monocytes, consistent with the mode of action of NOX-E36 – neutralization of chemokine monocyte chemoattractant protein-1 (MCP-1). This protein is a specific target in the inflammatory reaction cascade that causes recruitment of monocytes to sites of inflammation. It has recently been introduced as “adipokine” playing an important role in obesity and complications of type 2 diabetes. Its inhibition is thus anticipated to be of benefit for type 2 diabetes patients.
In addition, NOX-E36 showed excellent bioavailability after subcutaneous administration. This fact should make it possible to achieve a dosing regimen with at least once weekly administration. Final results and analysis for this phase I trial are expected by early 2010.
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.
Dr Frank Morich, CEO of NOXXON Pharma AG, commented: “The preliminary results of this phase I study are impressive and show that Spiegelmers® have the potential to become a novel class of broadly applicable therapeutic agents addressing large areas of unmet medical need. They also indicate that Spiegelmers® can be applied in convenient dosing regimens. In the meantime our other drug candidates are advancing rapidly towards clinical development.”