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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

Statistical Significance in Primary and Key Secondary Endpoints at Both Doses

Data Confirm Robust Sleep Onset and Sleep Maintenance Effects Seen in the First Phase II Study in the Adult Population

HAMBURG, Germany and OXFORD, England, October 16 /PRNewswire-FirstCall/ -- Evotec AG (Frankfurt Stock Exchange: EVT) announced today positive top-line results from its second phase II trial of EVT 201 in elderly primary insomnia patients with daytime sleepiness. These top-line results are from the pre-specified intention-to-treat analysis from the 149 patients who were randomised into the study.

The study showed a highly significant improvement between both doses of EVT 201 and placebo on the primary endpoint of polysomnography (PSG) derived Total Sleep Time (TST); compared to placebo, mean TST increased by 30.9 minutes (9%) on EVT 201 1.5 mg and 56.4 minutes (17%) on EVT 201 2.5 mg; p=0.0001 and p=<0.0001 respectively.

Significant improvements were also seen across key PSG-derived secondary endpoints including Wake After Sleep Onset (WASO) and Latency to Persistent Sleep (LPS). Although the study was not powered to show this, the 2.5 mg dose also showed a significant effect on TWT (Total Wake Time) during the second half of the night, indicating that EVT 201 is highly effective in maintaining sleep throughout the night. This was further confirmed by the hour-by-hour analysis of TWT. Treatment with EVT 201 produced a statistically significant reduction in TWT for all hours of the night apart from hour 7.

A randomized, double-blind, placebo-controlled parallel group design was used to assess the hypnotic efficacy of EVT 201 1.5 mg and 2.5 mg following 7 nights dosing. The study was conducted in 20 sleep labs in the US using both objective and subjective measures. PSG data were collected on nights 1, 6 and 7 and results are based on the mean data from these three nights.

The table below shows the results for the primary and key seco
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SOURCE Evotec AG
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