Intra-Cellular Therapies reports positive results from Phase II insomnia study

Intra-Cellular Therapies, a biopharmaceutical company, has announced positive final results from the ITI-007 Phase II trial in patients with sleep maintenance insomnia.

This Phase II trial was a double-blind, placebo controlled, four-way crossover design comparing placebo to three doses of ITI-007 (1mg, 5mg and 10mg) in patients with sleep maintenance insomnia.

In this study, ITI-007 significantly and dose-dependently increased slow wave sleep and decreased the duration of wake after sleep onset as measured by polysomnography (PSG), meeting the pre-specified primary and key secondary endpoints of the trial. ITI-007 also increased total sleep time and sleep efficiency, the company said.

Intra-Cellular Therapies believes that ITI-007 promotes natural, restorative sleep. In particular, ITI-007 did not cause rebound insomnia during early morning hours and did not suppress rapid eye movement sleep as some hypnotic agents do.

The present data also show that ITI-007 is sleep promoting without having sedative properties and should not exhibit adverse effects during the night (falls, amnesia) or next day hangover effects that are commonly associated with other sleep medications. ITI-007 is expected to have a strong safety profile with no addiction liability.

PSG improvements such as increased total sleep time and slow wave sleep are associated with reports of improved sleep quality. Improvement in these sleep parameters is driven by the unique pharmacology of ITI-007 that can act simultaneously as a 5HT2A receptor antagonist, dopamine receptor phosphoprotein modulator (DPPM), and inhibitor of serotonin reuptake. These additional actions clearly differentiate ITI-007 from other sleep modulating drugs, the company added. 

Sharon Mates, CEO of Intra-Cellular Therapies, said: We are excited to have demonstrated ITI-007’s ability to produce such robust improvements on sleep quality. We believe that the positive effects on sleep in this study are a result of ITI-007’s unique pharmacological profile that clearly differentiate it from currently available sleep inducing or sleep maintaining drugs. These data set the stage for further investigation of ITI-007’s ability to improve sleep in a wide variety of diseases where sleep improvement may be beneficial.