NOXXON Pharma (NOXXON) has reported the successful completion of the first phase I trial with its anti-inflammatory Spiegelmer NOX-E36. This drug candidate will be developed for the treatment of complications of type 2 diabetes, preferentially diabetic nephropathy.
Reportedly, the phase I study conducted in the UK 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.
The Preliminary results suggested NOX-E36 to be safe and well tolerated at all dose levels in both the intravenous and subcutaneous groups. NOX-E36 showed dose-linear pharmacokinetic.
However, pharmacodynamic evaluation indicates a dose-dependent decrease of peripheral blood monocytes, consistent with the mode of action of NOX-E36, neutralisation 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.
The company has informed that NOX-E36 showed an 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.
Additionally, 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.
Frank Morich, CEO of NOXXON, said: “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.”