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.
Jörn Aldag, President and Chief Executive Officer, Evotec AG, said: "We are very pleased with the positive outcome of this clinical trial. Our first drug with proof-of-concept in patients is a major milestone in Evotec's transition into a CNS focused biopharmaceutical company."
Commenting on the results, Dr John Kemp, Chief Research & Development Officer, Evotec AG, added: "We have always considered that EVT 201 has the potential to help patients to fall asleep quickly, help them stay asleep during the night and allow them to awake in the morning feeling refreshed and without any hang-over effect. It thereby meets the major needs of insomniac patients without the need for a sustained release formulation. These results confirm that potential in the primary patient population."
Dr Tim Tasker, Executive Vice President Clinical Development, Evotec AG, added: "The results provide our first evidence that this partial agonist is effective in patients. The profile shows large effects on sleep onset and maintenance without any subjective evidence of hang-over the next day."
Principal Investigator Dr James Walsh, Executive Director of the Sleep Medicine and Research Center, St John's Mercy Medical Center, Chesterfield, Missouri, US, said: "This first study of EVT 201 in patients provided highly significant and robust effects upon polysomnographically measured sleep for both doses. In addition patients reported an improved quality of sleep. Ratings of alertness in the morning were not impaired and findings on DSST were quite small. These are encouraging results which offer significant promise for the drug as a treatment for insomnia patients."
A second Phase II clinical trial of EVT 201 in elderly patients