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Intra-Cellular Therapies concludes enrollment in Phase 3 clinical trial of ITI-007 for the treatment of schizophrenia.

M2 EQUITYBITES-June 16, 2015-Intra-Cellular Therapies concludes enrollment in Phase 3 clinical trial of ITI-007 for the treatment of schizophrenia


Biopharmaceutical company Intra-Cellular Therapies (NasdaqGS:ITCI) said on Monday that it has enrolled 450 adult patients under the first Phase 3 clinical trial (ITI-007-301) of its lead product candidate ITI-007 in patients with schizophrenia, a disabling and chronic mental illness affecting over 1% of the world's population.

This first Phase 3 clinical trial was conducted in clinical sites throughout the US and the company anticipates topline data will be available in the second half of 2015.

The company's Phase 3 clinical trial, called ITI-007-301, is a randomized, double-blind, placebo-controlled clinical trial in patients with an acutely exacerbated episode of schizophrenia. In this trial, 450 patients were randomized to receive one of three treatments: 60 mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio.

Additionally, the patients received study treatment orally once daily in the morning for 28 days. Enrollment has completed and clinical conduct is ongoing. Clinical conduct includes a 1-week screening period before randomization and then a 28 day treatment period.

Prior to discharge from the company's study, the patients are switched to a standard-of-care treatment for schizophrenia during a five day inpatient stabilization period. Patients are instructed to return for a safety follow-up visit on study day 42. Additional time is planned to complete data entry to conduct statistical analyses.

According to the company, the primary endpoint for this clinical trial is change from baseline versus placebo at Day 28 on the Positive and Negative Syndrome Scale (PANSS) total score using a Mixed-Effect Model Repeated Measure method for handling missing data in the intent-to-treat (ITT) study population.

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Publication:M2 EquityBites (EQB)
Date:Jun 16, 2015
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