Hamburg, Germany | Oxford, UK - Evotec AG (Frankfurt Stock Exchange, Prime Standard, ISIN: DE 000 566480 9, WKN 566480) announced today positive top-line results from its first phase II clinical trial of EVT 201 in patients with chronic primary insomnia. 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-tolerated at both doses without any serious adverse events. Further analysis of the remaining secondary endpoints is ongoing.
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