Hamburg, Germany - Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX 30, "Evotec") announced today the initiation of a Phase II clinical trial with EVT 201 for the treatment of insomnia under a US IND. This US, multi-centre, double-blind trial is designed to evaluate the efficacy of EVT 201 in a three way cross-over design in 66 patients with primary insomnia. Patients will receive two dose levels of EVT 201 and placebo, in a random order, for two consecutive nights with a 5-12 day washout between each period. The doses were chosen based on the results obtained from previous Phase I/II proof-of-principle trials.
In two Phase I/II studies using the traffic noise model of insomnia in healthy male volunteers, EVT 201 significantly reduced "wake after sleep onset" (WASO) while significantly increasing "total sleep time" (TST) and quality of sleep with no subjective residual effects. The compound was well tolerated without significant adverse events.
Dr John Kemp, Chief Research & Development Officer at Evotec, commented: "The results of our previous studies of EVT 201 in a traffic noise model of insomnia in healthy volunteers were extremely encouraging. If we can confirm this profile of efficacy together with freedom from significant adverse effects in patients with primary insomnia, this would represent a very attractive product profile in a market in which we believe there are significant opportunities based on a high unmet medical need."
The trial is led by principle investigator James Walsh, Executive Director of the Sleep Medicine and Research Center, St John's Mercy Medical Center, Chesterfield, Missouri, US with co investigators at sleep research centres across the United States.
The primary endpoints of this first patient trial with EVT 201 are to assess "wake after sleep onset" (WASO) as well as "total sleep time" (TST) determined by polysomnography. The secondary endpoints include additional measures such as latency to persistent sleep and number of awakenings. In addition, effects on sleep architecture will be examined and patients will evaluate sleep quality and quantity.
Contact: Anne Hennecke, Director, Investor Relations & Corporate Communications, Evotec AG, Phone: +49-40-56081-286, anne.hennecke@evotec.com
In two Phase I/II studies using the traffic noise model of insomnia in healthy male volunteers, EVT 201 significantly reduced "wake after sleep onset" (WASO) while significantly increasing "total sleep time" (TST) and quality of sleep with no subjective residual effects. The compound was well tolerated without significant adverse events.
Dr John Kemp, Chief Research & Development Officer at Evotec, commented: "The results of our previous studies of EVT 201 in a traffic noise model of insomnia in healthy volunteers were extremely encouraging. If we can confirm this profile of efficacy together with freedom from significant adverse effects in patients with primary insomnia, this would represent a very attractive product profile in a market in which we believe there are significant opportunities based on a high unmet medical need."
The trial is led by principle investigator James Walsh, Executive Director of the Sleep Medicine and Research Center, St John's Mercy Medical Center, Chesterfield, Missouri, US with co investigators at sleep research centres across the United States.
The primary endpoints of this first patient trial with EVT 201 are to assess "wake after sleep onset" (WASO) as well as "total sleep time" (TST) determined by polysomnography. The secondary endpoints include additional measures such as latency to persistent sleep and number of awakenings. In addition, effects on sleep architecture will be examined and patients will evaluate sleep quality and quantity.
Contact: Anne Hennecke, Director, Investor Relations & Corporate Communications, Evotec AG, Phone: +49-40-56081-286, anne.hennecke@evotec.com