The double-blind, placebo controlled cross-over study of two doses of EVT 201 (1.5mg and 2.5mg) in 67 completed patients was conducted in sleep labs in the US using objective polysomnography (PSG).
Evotec says its analysis showed that all endpoints achieved an even higher level of statistical significance than first indicated. The pre-specified intention-to-treat analysis of the study showed that on both of the co-primary endpoints of total sleep time (TST) and wake after sleep onset (WASO) the statistical significance of both doses against placebo was p<0.0001. Highly statistically and clinically meaningful effects were also found on both the latency to persistent sleep (LPS) and TST in the second half of the night, indicating strong effects on both sleep onset and sleep maintenance. In addition to these objective PSG results, Evotec says there were highly significant improvements, at both dose levels, on the subjective perception of sleep quality. The large effect size on total wake time (TWT) for the second half of the night, 32.1 (25%) and 26.7 (38%) for primary and secondary endpoints respectively, indicates that EVT 201 is highly effective in maintaining sleep throughout the night, according to the company. This was further confirmed by the hour-by-hour analysis of TWT. Although the study was not powered for such an analysis, the reduction in TWT produced by EVT 201 was statistically significant for all hours of the night apart from hour 7 which came very close to reaching statistical significance (p= 0.058). Commenting on the results, Dr John Kemp, chief R&D officer, Evotec, said: “The magnitude of effect on sleep maintenance appears more robust than those seen with other agents in similar cross-over design studies. In particular, we are not aware of similar studies that have demonstrated such statistically significant effects on total wake time in the second half of the night and total wake time each hour.”