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Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
Date:3/10/2009

revealed dose-related increases in exposure to ITI-007 and two metabolites with increasing dose.

These robust improvements in sleep suggest that ITI-007 will have utility in treating not only sleep maintenance insomnia but also other disorders associated with fragmented sleep including many neuropsychiatric (e.g. major depression, bipolar disorder, PTSD, mild cognitive impairment and schizophrenia) and neurological diseases (e.g. Parkinson's and Alzheimer's diseases).

ABOUT SLEEP MAINTENANCE DISORDERS

From insomnia to sleep apnea, sleep disorders disrupt the sleep of millions of people all over the world. In particular, about 20% to 30% of the U.S. population complains of waking up frequently during the night or too early several times a week, symptoms of SMI that are characterized by difficulty staying asleep and unrefreshing sleep. In many populations (e.g. the elderly) the majority of sleep complaints are related to SMI rather than sleep initiation or difficulty in falling asleep. In addition, this type of sleep disruption is common in patients with depression, bipolar disorder and other mood disorders, Alzheimer's disease (AD) and neurological disorders. For example, sleep disturbances in patients with Alzheimer's disease is one of the primary reasons that persons with AD are institutionalized. There is a significant need for sleep medications that improve sleep in patients with neuropsychiatric and neurologic disorders and comorbid sleep disorders.

ABOUT ITI-007

ITI-007 is the Company's first-in-class dual 5HT2A receptor antagonist/dopamine receptor phosphoprotein modulator (DPPM) for the treatment of schizophrenia. ITI-007 has dual properties; it acts as a post-synaptic antagonist and as a pre-synaptic partial agonist. The combination of ITI-007's high-potency blockade of 5HT2A receptors and unique dopamine receptor activity should allow a personalized a
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SOURCE Intra-Cellular Therapies, Inc.
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