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Evotec Reports Details of the Positive Proof-of-Concept Phase II Study in Insomnia With EVT 201
Date:9/5/2007

so showed that EVT 201 did not have a negative impact on sleep architecture unlike many benzodiazepine full agonists.

As in all previous clinical studies, EVT 201 was demonstrated to be safe and well-tolerated at both doses. No serious or unexpected adverse events were reported.

The table below shows the actual results for each of the primary and selected secondary endpoints:

Parameter Placebo EVT 201 EVT 201

N=67 1.5 mg 2.5 mg

Adjusted mean WASO (mins) 47.2 (26%) 38.2 (40%)

63.9 p<0.0001 p<0.0001

Adjusted mean TST (mins) 412 (9%) 424 (12%)

379 p<0.0001 p<0.0001

Adjusted mean LPS (mins) 25.2 (40%) 21.6 (49%)

42.3 p<0.0001 p<0.0001

Adjusted mean Total Wake 32.1 (25%) 26.7 (38%)

Time 2nd half (mins)

42.9 p=0.0008 p<0.0001

Adjusted mean Slow Wave 30.4 (2.4%) 29.9 (0.7%)

Sleep (mins)

29.7 NS NS

Subjective sleep quality 75.2% 78.7%

(very good/good) 41.2 % p<0.0001 p<0.0001

Adjusted mean DSST 56.2 54.3

(number correct) 58.5 p= 0.0028 p<0.0001

Subjective residual

sedation

57.6% 48.0%

(very alert/somewhat

alert in %) 52.6 % NS NS

The large effect size on Total Wake Time (TWT) for the second half of the night indicates that EVT 201 is highly effective in maintaining sleep throughout the night. This was further confirmed by the hour-by-hour analysis of TWT. Although the study was not powered for such an analysis, the reduc
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SOURCE Evotec AG
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