Evotec to Host a Conference Call Today at 11:00 am CET (10:00 am UK time,5:00 am EST, 7:00 pm AEST) Directly From the Worldsleep07 Congress inAustralia
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HAMBURG, Germany and OXFORD, England, September 5 /PRNewswire-FirstCall/-- Evotec AG (Frankfurt Stock Exchange: EVT) presented today at theworldsleep07 congress in Cairns, Australia the details of the results fromits first Phase II clinical trial of EVT 201 in patients with primaryinsomnia. EVT 201 is a partial positive allosteric modulator (pPAM) of theGABAA receptor complex. The double-blind, placebo controlled cross-over studyof two doses of EVT 201 (1.5mg and 2.5mg) in 67 completed patients wasconducted in sleep labs in the US using objective polysomnography (PSG).After having published top-line results in a press release on 4 June 2007,the results of the detailed analysis are herewith reported.
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The detailed analysis showed that all endpoints achieved an even higherlevel of statistical significance than first indicated. The pre-specifiedintention-to-treat analysis of the study showed that on both of theco-primary endpoints of Total Sleep Time (TST) and Wake After Sleep Onset(WASO) the statistical significance of both doses against placebo wasp<0.0001.
Highly statistically and clinically meaningful effects were also found onboth the Latency to Persistent Sleep (LPS) and TST in the second half of thenight, indicating strong effects on both sleep onset and sleep maintenance.In addition to these objective PSG results, there were highly significantimprovements, at both dose levels, on the subjective perception of sleepquality.
The following morning there was no subjective perception of any residualsedation. The Digit Symbol Substitution Test (DSST) showed a small butclinically insignificant change tested the next day 9 h after dosing.
The PSG analysis also showed that EVT 201 did not have a negative impacton sleep architecture unlike many benzodiazepine full agonists.
As in all previous clinical studies, EVT 201 was demonstrated to be safeand well-tolerated at both doses. No serious or unexpected adverse eventswere reported.
The table below shows the actual results for each of the primary andselected secondary endpoints:
The large effect size on Total Wake Time (TWT) for the second half of thenight indicates that EVT 201 is highly effective in maintaining sleepthroughout the night. This was further confirmed by the hour-by-hour analysisof TWT. Although the study was not powered for such an analysis, thereduction in TWT produced by EVT 201 was statistically significant for allhours of the night apart from hour 7 which came very close to reachingstatistical significance (p= 0.058).
Commenting on the results, Dr John Kemp, Chief Research & DevelopmentOfficer, Evotec AG, said: "I'm absolutely delighted with the results of thisproof-of-concept Phase II study. The magnitude of effect on sleep maintenanceappears more robust than those seen with other agents in similar cross-overdesign studies. In particular, we are not aware of similar studies that havedemonstrated such statistically significant effects on Total Wake Time in thesecond half of the night and Total Wake Time each hour."
Jorn Aldag, President and Chief Executive Officer, Evotec AG, said:"Although certain aspects of insomnia are addressed by current treatments,there is no drug yet available which meets all the needs of insomniapatients. In our study EVT 201 demonstrated extremely robust findings on allkey aspects of the problems faced by insomniacs, i.e. sleep onset and sleepmaintenance and yet was without the patients feeling any drug hang-overeffects after waking in the morning. We believe this gives EVT 201 a verycompetitive profile compared to the currently available
