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news.Evotec has started its first Phase II study for EVT 302 in smoking cessation, a reversible and highly selective inhibitor of monoamine oxidase B or MAO-B.
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This double-blind, three-way cross-over study is designed to investigate the influence of EVT 302 on craving and withdrawal symptoms after short-term deprivation of cigarettes in 90 smokers. Smokers will receive a single dose of EVT 302, nicotine, and placebo in a random order. The effect of EVT 302 on craving when combined with nicotine replacement therapy will be assessed as a secondary outcome. In addition, safety and tolerability as well as additional outcome parameters relating to exposure and MAO-B inhibition will be investigated. The results are expected to be reported in the third quarter of 2008.
This is one of two Phase II studies planned to be initiated in 2008 as part of the clinical development program of EVT 302 in smoking cessation. The second study to access the impact of EVT 302 on the quit rate of heavy smokers withdrawing from cigarettes is expected to start in mid 2008.
John Kemp, chief R&D officer at Evotec, said: “Evotec is extremely proud to have progressed its second drug candidate into Phase II clinical trials. I am extremely pleased with the safety and tolerability profile of EVT 302 in young and elderly subjects emerging from Phase I studies and look forward to continued progress with this compound.”