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Evotec Reports Positive Proof-of-Concept Top-Line Results with,Insomnia Drug Candidate EVT 201

Both Co-Primary Endpoints, Wake After Sleep Onset and Total Sleep Time, and Key Secondary Endpoints, Including Latency to Persistent Sleep, Were Met at Both Doses

HAMBURG, Germany and OXFORD, England, June 04, 2007 /PRNewswire-FirstCall/ -- Evotec AG announced today positive top-line results from its first phase II clinical trial of EVT 201 in patients with chronic primary insomnia. EVT 201 is a partial positive allosteric modulator (pPAM) of the GABAA receptor complex. The double-blinded, placebo controlled cross-over study design of two doses of EVT 201 (1.5mg and 2.5mg) in 67 patients was conducted in sleep labs in the US using objective polysomnography. The pre-specified intention-to-treat analysis of the study showed statistically highly significant improvements between both doses of EVT 201 and placebo in both of the co-primary endpoints of Total Sleep Time (TST) (p<0.001) and Wake After Sleep Onset (WASO) (p<0.001). Notably, WASO during the second half of the night was also significantly (p<0.001) reduced, indicating that EVT 201 has efficacy in sleep maintenance throughout the night.

Improvements were also seen across pre-specified secondary endpoints. Latency to persistent sleep was markedly decreased by both doses of EVT 201 (p<0.001) and patients reported highly significant improvements in subjectively assessed quality of sleep (p<0.001 both doses). Treatment with EVT 201 was completely without effect on subjectively assessed residual sedation the next day and produced only a small decremental effect on the digital symbol substitution test (DSST) assessed at nine hours post dosing. Initial analysis showed that EVT 201 did not impair slow wave sleep unlike many benzodiazepine full agonists. The study therefore demonstrated EVT 201 has robust effects on both sleep onset and sleep maintenance and is without meaningful next day hang-over effects.

EVT 201 was demonstrated to be safe and well
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