Evotec AG (Frankfurt Stock Exchange, Prime Standard, ISIN: DE 000 566480 9, WKN 566480) today completed the top-line analysis of its double-blind, placebo-controlled, parallel group design phase II trial of EVT 201 1.5 mg and 2.5 mg in 149 elderly primary insomnia patients with daytime sleepiness.
The study confirms the excellent profile of EVT 201 as a potential treatment that helps patients to fall asleep quickly, maintains their sleep throughout the night and yet enables them to wake in the morning without hangover effects and feeling like they've had a good night's sleep.
The study showed a highly significant improvement between both doses of EVT 201 and placebo on the primary endpoint of polysomnography (PSG) derived Total Sleep Time (TST). Significant improvements were also seen across key PSG-derived secondary endpoints including Wake After Sleep Onset (WASO) and Latency to Persistent Sleep (LPS). Subjectively, no residual sedation was observed 30-minutes post wake time.
Initial analyses also showed that both doses of EVT 201 produced a statistically significant overall improvement in the Multiple Sleep Latency Test (MSLT) compared to placebo, indicating that patients were less sleepy during the day following treatment with EVT 201. Further analysis of this and other measures of daytime function are ongoing.
EVT 201 was well tolerated. No serious treatment emergent adverse events were reported during the study.
The results of this study in the elderly confirm the robust effects of EVT 201 on sleep onset and sleep maintenance seen in the adult population in Study 2004 and indicate that the same doses 1.5 mg and 2.5 mg have hypnotic efficacy in the elderly with no significant residual effects.
Contact: Anne Hennecke, SVP, Investor Relations & Corporate Communications, Evotec AG, Schnackenburgallee 114, 22525 Hamburg, Germany, Phone: +49.(0)40.560 81-286, firstname.lastname@example.org