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news.Germany-based Evotec has completed a Phase I safety and tolerability study with EVT 302, a reversible and highly selective inhibitor of MAO-B in development for smoking cessation.
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The company said that preliminary results confirm the good tolerability profile of EVT 302 and are an encouraging basis for further clinical development.
EVT 302 was investigated in an ascending dose study with repeated daily dosing in a total of 84 healthy young and elderly subjects. Healthy young male subjects were treated with EVT 302 2.5mg, 5mg, 15mg, or placebo for two weeks, and healthy elderly male and female subjects were treated with EVT 302 2.5mg, 10mg, or placebo for four weeks.
The study was aimed at investigating safety/tolerability, pharmacokinetics, and pharmacodynamics (inhibition of MAO-B in platelets) during prolonged dosing with EVT 302 as compared to placebo.
The preliminary data indicate that EVT 302 was well tolerated in young and elderly subjects up to the highest dose levels tested in this study. Only very few moderate adverse events (AEs) were reported. No severe or serious AEs occurred.