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Evotec Reports Positive Top-Line Results in Phase II Study With EVT 201 in Elderly Insomniacs With Daytime Sleepiness
Date:10/16/2007

ely by using the Multiple Sleep Latency Test (MSLT), the Psychomotor Vigilance Task (PVT), a measure of sustained attention and reaction time, the Rey Auditory Verbal Learning Test (RAVLT), a short-term verbal memory test and subjectively using the Karolinska Sleepiness Scale (KSS). Residual sedation was assessed 30 minutes post wake time subjectively using a categorical rating scale. Safety measures included adverse events, laboratory data and the Benzodiazepine Withdrawal Questionnaire.

About EVT 201

EVT 201 is a partial positive allosteric modulator (pPAM) of the GABAA receptor complex. Acting on GABAA receptors it addresses the gold standard mechanism for insomnia with more than 90% of current insomnia drugs using this mechanism. Importantly, however, its close to ideal half life of 3 to 4 hours and its partial agonist activity gives EVT 201 a differentiated preclinical profile and mechanism of action.

The results of the first Phase II study with EVT 201 in adult primary insomnia patients were very positive in terms of all key aspects of the problems faced by insomniacs, i.e. sleep onset and sleep maintenance and yet the patients didn't feel any drug hang-over effects after waking in the morning.

Furthermore, in two previous Phase I/II proof-of-principle studies in subjects with induced insomnia, EVT 201 significantly reduced Wake After Sleep Onset (WASO) while significantly increasing the Total Sleep Time (TST) and quality of sleep with no subjective residual effects. The studies were conducted in a sleep laboratory setting using the traffic noise model of insomnia in healthy male volunteers. In this setting an average of 52 decibels of recorded traffic noise is played throughout the night thereby provoking insomnia. This model has been used to evaluate several insomnia treatments currently in development and on the market.

EVT 201 showed no tolerance/dependence liabilities in pre-clinical studies and no interaction with alcohol.'/>"/>

SOURCE Evotec AG
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