Hamburg, Germany - Evotec AG (Frankfurt Stock Exchange, Prime Standard, ISIN: DE 000 566480 9, WKN 566480) today initiated a Phase II clinical trial with EVT 201 for the treatment of insomnia under a US IND. This US, multi-centre, double-blind trial is designed to evaluate the efficacy of EVT 201 in a three way cross-over design in 66 patients with primary insomnia. The primary endpoints of this first patient trial with EVT 201 are to assess "wake after sleep onset" (WASO) as well as "total sleep time" (TST) determined by polysomnography.
In two Phase I/II studies using the traffic noise model of insomnia in healthy male volunteers, EVT 201 significantly reduced "wake after sleep onset" (WASO) while significantly increasing "total sleep time" (TST) and quality of sleep with no subjective residual effects. The compound was well tolerated without significant adverse events. The study initiated today is to confirm this promising profile of efficacy together with freedom from significant adverse effects in insomnia patients. It is the first Phase II study and the first US study Evotec has conducted.
Contact: Anne Hennecke, Director, Investor Relations & Corporate Communications, Evotec AG, Schnackenburgallee 114, 22525 Hamburg, Germany, Phone: +49.(0)40.560 81-286, firstname.lastname@example.org