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Phase I Safety and Tolerability Study With EVT 302 Successfully Completed
Date:1/7/2008

s, in any subjects.

About EVT 302

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.

Two further Phase I studies with EVT 302 are currently ongoing: In March 2007, Evotec initiated a positron emission tomography (PET) study designed to assess the occupancy of MAO-B in the brain after the oral administration of EVT 302 in patients. This technique helps to determine the therapeutic dose range of EVT 302 for subsequent safety and efficacy studies. The study is expected to be completed in early 2008.

In November 2007, Evotec initiated a Phase I tyramine interaction study to confirm that there was no cardiovascular liability with foods that contain high amounts of tyramine. A first Phase II study to examine the effects of EVT 302 on craving following smoking cessation is planned to start in Q1 2008.

About Smoking Cessation

The market potential for smoking cessation therapies is enormous. There are 44.5 million smokers in the US alone, 70% of which report a desire to quit, and the average smoker will make six to nine attempts to quit during their lifetime. There is also strong health economic support for the benefits of quitting. The market is dominated by nicotine replacements such as patch and gum, and only two prescription therapies are currently approved. Any drug that could im
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SOURCE Evotec AG
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