Evotec's smoke cessation drug completes Ph I trial

Germany's Evotec AG has completed a Phase I safety and tolerability study with EVT 302, a reversible and highly-selective inhibitor of monoamine oxidase-B in development for smoking cessation. The preliminary results confirm the good tolerability profile of the agent and are an encouraging basis for further clinical development, the firm says.

The drug was investigated in an ascending dose study with repeated daily administration in a total of 84 healthy young and elderly subjects. Healthy young male subjects were treated with 2.5mg, 5mg and 15mg doses of the agent or placebo for two weeks, and healthy elderly male and female subjects were treated with 2.5mg, 10mg or placebo for four weeks. According to the firm, the study was conducted and completed as planned per protocol but noted that the results are still blinded and will become available as final evaluated data over the next two months although preliminary data indicate that EVT 302 was well tolerated in young and elderly subjects up to the highest dose levels tested in this study. Adverse events classified as possibly treatment related were transient and mostly of mild intensity; only very few moderate AEs were reported. No severe or serious AEs occurred, Evotec added.