Intra-Cellular Therapies Inc, New York, released final results from the Phase II trial of ITI-007 in patients with sleep maintenance insomnia. The trial showed ITI-007 significantly and dose-dependently increased slow wave sleep and decreased the duration of wake after sleep onset as measured by polysomnography. These results meet the primary and key secondary endpoints of the trial.
ITI-007 is differentiated from other sleep modulating drugs due to its unique pharmacology that can act simultaneously as a 5HT2A receptor antagonist, dopamine receptor phosphoprotein modulator, and inhibitor of serotonin reuptake.
“We are excited to have demonstrated ITI-007’s ability to produce such robust improvements on sleep quality,” said Sharon Mates, chief executive officer of Intra-Cellular, in a press release about the trial. “We believe that the positive effects on sleep in this study are a result of ITI-007’s unique pharmacological profile that clearly differentiates it from currently available sleep inducing or sleep maintaining drugs.”