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Intra-Cellular Therapies Initiates Phase 2 Clinical Trial for Sleep Maintenance Insomnia
Date:12/20/2007

e all over the world. In particular, about 20% to 30% of the U.S. population complains of waking too early several times a week, a symptom of sleep maintenance insomnia (SMI) that is characterized by symptoms that include waking up frequently during the night with difficulty returning to sleep, waking up at early hours, and unrefreshing sleep. The majority of sleep complaints are related to SMI rather than sleep initiation or difficulty in falling asleep. However, there are no drugs currently approved in the U.S. that address only SMI. Furthermore, current sleep medications typically induce sedation and result in significant increases in daytime sleepiness that impairs quality of life in these patients. There is, therefore, a significant need for sleep medications that improve sleep quality without next-day hangover effects.

ABOUT ITI-722

ITI-722 is a highly potent 5HT2A antagonist for the treatment of sleep maintenance insomnia. Preclinical data has shown that ITI-722 is not sedating and should not exhibit next-day hangover effects that are commonly associated with other sleep medications. ITI-722 is expected to have a strong safety profile with no addiction liability. This compound is being evaluated for the treatment of sleep disorders in various patient populations with sleep maintenance problems and in other sleep disorders where staying asleep affects the quality of life, including nocturnal awakenings related to osteoarthritic pain, hot flashes in post-menopausal women and many psychiatric and neurodegenerative diseases.

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The Company has developed a state-of-the-art technology platform, called CNSProfile(TM), that is capable of generating a unique molecular signature for drug compounds. Specifically, CNSProfile(TM) measures the levels of phosphoproteins, proteins chemically linked at specific sites to phosphates. This profile provides the Company with a proprietary and unique window into the intracellular action
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SOURCE Intra-Cellular Therapies, Inc.
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