Evotec Initiates its First Phase I Clinical Study with EVT 302
Evotec AG announced the initiation of its first Phase I study with EVT 302. This open-label study is designed to access the occupancy of the monoamine oxidase B enzyme (MAO-B) in brain after administration of single oral doses of EVT 302 by the use of dynamic positron emission tomography (PET). This technique helps to determine the therapeutic dose range of EVT 302 for the upcoming safety and efficacy studies.
EVT 302 is an orally active, potent, highly selective and reversible inhibitor of MAO-B in development for smoking cessation. Its preclinical profile supports the potential for a superior safety profile over marketed MAO-B inhibitors and better tolerability compared to current treatments. In a Phase I single ascending dose study at Roche from whom the compound was in-licensed, EVT 302 was safe and well tolerated up to high dose levels and showed excellent pharmacokinetic properties with prolonged MAO-B inhibition offering the potential for once a week dosing at very low exposure levels. This could be a significant advantage for a condition where smokers' motivation for quitting can vary from day to day.
Evotec plans to start additional Phase I safety and tolerability studies during the first half of 2007. If the Phase I results are positive, Phase II in smoking cessation is planned to begin in mid 2008.
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