Evotec Announces Positive Phase I/II Clinical Trial Results with Insomnia Treatment EVT 201

Hamburg, Germany | Oxford, UK - Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX 30) announced today top-line results of the proof-of-principle study for its GABA-A modulator EVT 201, for the treatment of insomnia. The Phase I/II study, which was conducted in an established clinical model of insomnia in healthy adults, has been completed with positive results. EVT 201 significantly reduced wake after sleep onset (WASO) while significantly increasing the total sleep time and quality of sleep with no subjective residual effects. As with previous clinical studies, the compound was well tolerated without significant adverse events.  
The drug was tested at four doses and placebo, a dose-response relationship was established with significant efficacy at the top three doses.
Prof Anthony Nicholson, Principal Investigator, commented: "This is a second dose ranging trial carried out here at the Human Psychopharmacology Research Unit of the University of Surrey. In both studies the 2.5 mg dose improved sleep quality and sleep maintenance through the night. Of particular interest was that improved sleep continuity was accompanied by a marked increase in deep (slow wave) sleep. There were no subjective reports of residual effects and no cognitive and psychomotor effects were observed 10 hours after dosing. This profile of efficacy together with freedom from significant adverse effects suggests that EVT 201 holds much promise in the management of insomnia." 
Dr John Kemp, Executive Vice President Research & Development at Evotec, added: "Approximately 50% of the adult population experience symptoms of insomnia on a regular basis. Only a fraction, however, are using a sleep aid. The results indicate that EVT 201 is a substance that could help people fall asleep quickly, stay asleep throughout the night and allow them to awake without feeling residual effects. If this profile is confirmed in phase II patient trials, it could represent a significant step forward in the treatment of this significant and underserved medical condition. Importantly, we now understand the dose-response relationship of EVT 201 allowing us to select the optimal doses for the upcoming Phase II clinical trials."
Study design
The phase I/II clinical trial was a double-blind, placebo controlled, cross-over trial designed to determine the efficacy and side effects of 4 doses (1.0, 1.5, 2.0 and 2.5 mg) of EVT 201 compared to placebo in 12 volunteers. Each subject received in a randomised fashion all treatments once with at least a week between treatments.
The study was conducted in a sleep laboratory setting using the traffic noise model of insomnia in healthy male volunteers. In this setting recorded traffic noise is played throughout the night thereby provoking insomnia. Sleep was measured using the measurement techniques of polysomnography and a battery of psychometric tests, as well as subjective assessments. This is a well accepted model for investigating compounds for this indication and has been used with several compounds currently in development.  

Contact: Anne Hennecke, Director, Investor Relations & Corporate Communications, Evotec AG, Phone: +49-40-56081-286, anne.hennecke@evotec.com
Contact: Anne Hennecke, Director, Investor Relations & Corporate Communications, Evotec AG, Phone: +49-40-56081-286, anne.hennecke@evotec.com