Intra-Cellular Therapies (ITCI) Presents Encouraging Data from Three ITI-007 Trials at CNS Summit

October 31, 2016 8:12 AM EDT

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Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced presentation (in oral and poster forms) of results from its clinical development program in schizophrenia that has replicated the efficacy of ITI-007 60 mg in two studies and found it to be safe and well tolerated in three large, well-controlled clinical trials: ITI-007-005, ITI-007-301 and ITI-007-302. Results from these trials were presented at the CNS Summit 2016 Annual Conference, held in Boca Raton, Florida October 27-30.

Across all three trials, ITI-007 60 mg improved symptoms of schizophrenia with a similar trajectory and magnitude of improvement from baseline to endpoint on the primary efficacy measure, the PANSS total score. These robust improvements in psychotic symptoms were statistically significant versus placebo in Studies ‘005 and ‘301 but not in Study ‘302 due in part to an unusually high placebo response. In all three of these studies, ITI-007 was well-tolerated and exhibited a safety profile similar to placebo. In addition, in the studies where risperidone was used as the active control (Studies ‘005 and ‘302), ITI-007 was statistically significantly better than risperidone on key safety and tolerability parameters. The Company believes that the two large, well-controlled positive studies (‘005 & ‘301) along with supportive findings from the third study (‘302) collectively provide evidence of the efficacy and safety of ITI-007 for the treatment of schizophrenia.

The Company’s CNS summit poster presentation can be found on our website, available here. The Company will present additional analyses from the ITI-007 schizophrenia program at future scientific conferences.

“We are excited that our schizophrenia clinical development program to date has replicated the efficacy of ITI-007 60 mg in two large well-controlled studies and we are encouraged that these data and additional data from study '302, again describing a placebo-like safety profile with clinical advantages over risperidone, have been so well-received by the medical community at CNS Summit. We look forward to advancing this new treatment option for patients and to discussing the totality of these data with the FDA,” said Dr. Sharon Mates, Chairman and CEO of ITCI.

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