Intra-Cellular Commences Phase III Schizophrenia Study

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Intra-Cellular Therapies, Inc. (ITCI) announced that it has enrolled the first patient in a randomized, double-blind, placebo-controlled phase III study (ITI-007-301) on its lead candidate, ITI-007, for the treatment of schizophrenia.

The primary endpoint of this study will measure the ability of ITI-007 to reduce the severity of schizophrenic symptoms in terms of change from baseline to day 28. Top-line results from this study should be out in the fourth quarter of 2015.

Intra-Cellular Therapies intends to initiate a second phase III study (ITI-007-302) on ITI-007 for the same indication in the first half of 2015. The company is targeting the submission of a new drug application for ITI-007 for the treatment of schizophrenia in late 2016/early 2017.

Currently approved schizophrenia treatments include AstraZeneca’s (AZN) Seroquel XR as well as Pfizer’s (PFE) Geodon.

Meanwhile, Intra-Cellular Therapies is evaluating ITI-007 in other neuropsychiatric and neurological indications. In 2015, the company intends to commence a phase II program on ITI-007 in patients with behavioral disturbances associated with dementia and related disorders including Alzheimer's disease. Additionally, the company plans to conduct studies on ITI-007 for the treatment of bipolar disorder following its discussions with the FDA.

Additionally, the company is also developing ITI-214 for the treatment of central nervous system disorders, cardiovascular diseases and other disorders.

With several upcoming studies on the company’s lead candidate, we expect investors to focus on updates on ITI-007.

Intra-Cellular Therapies currently, carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Biogen Idec Inc. (BIIB), carrying a Zacks Rank #1 (Strong Buy).

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