Intra-Cellular Therapies (ITCI) Announces ITI-007 Phase 3 Missed Primary Endpoint in Schizophrenia
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Intra-Cellular Therapies Announces Top-Line Results from the Second Phase 3 Trial of ITI-007 in Patients with Schizophrenia (Study ‘302)
September 28, 2016 4:01 PM EDTNEW YORK, Sept. 28, 2016 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) today announced top-line results from the second Phase 3 clinical trial (Study 302) of ITI-007, an oral, first-in-class investigational medicine for the treatment of schizophrenia. In this trial, neither dose of ITI-007 separated from placebo on the primary endpoint, change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score, in the pre-defined patient population. The active control, risperidone, did separate from placebo. Â In this trial, ITI-007 was statistically significantly better than risperidone on key safety and tolerability parameters and exhibited a... More
