Ad hoc: Evotec AG: Evotec Reports Positive Proof-of-Concept Top-Line Results with
Insomnia Drug Candidate EVT 201
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, anne.hennecke@evotec.com
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Evotec AG
Schnackenburgallee 114 Hamburg Germany
WKN: 566480; ISIN:
DE0005664809 ; Index: Prime All Share, CDAX, HDAX, MIDCAP, TECH All
Share;
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