Intra-Cellular says late-stage trial of ITI-007 in schizophrenia hits main goal

Intra-Cellular Therapies announced Wednesday that in a Phase III study of patients with schizophrenia, a higher dose of the experimental drug ITI-007 met the primary endpoint. "We are very encouraged by the positive results," remarked CEO Sharon Mates, adding "the antipsychotic effect of 60 mg is confirmed and shows itself to be well tolerated along with a safety profile similar to placebo." Shares in the company rose as much as 42 percent on the news.

The ITI-007-301 trial randomised 450 patients with schizophrenia who had an acute exacerbation of psychotic symptoms to receive either a 40-mg or 60-mg dose of ITI-007 or placebo once daily in the morning for four weeks. The study's pre-specified primary efficacy measure was change from baseline versus placebo at study endpoint on the centrally rated Positive and Negative Syndrome Scale (PANSS) total score. The company noted that patients had a mean PANSS score of 89.8 at baseline, which was "indicative of being markedly ill." Meanwhile, the key secondary endpoint was the centrally rated Clinical Global Impression Scale for Severity of Illness (CGI-S).

According to Intra-Cellular, ITI-007 dosed at 60 mg demonstrated significant antipsychotic efficacy versus placebo at week four. Specifically, patients taking ITI-007 had mean improvements in their PANSS scores of 14.5 points, compared with 10.3 for placebo. The company further indicated that the 60-mg dose exhibited significant antipsychotic efficacy as early as the first week, which was maintained throughout the study. Intra-Cellular noted that although the 40-mg dose of ITI-007 showed a dose-related improvement in symptoms of schizophrenia, it did not reach statistical significance.

The drugmaker added that the higher dose of the drug also met the secondary goal of a significant improvement on the CGI-S score. Intra-Cellular said that the 40-mg dose of ITI-007 also demonstrated a significant improvement versus placebo on the CGI-S, although the dose was not formally tested against placebo as it had failed to meet the primary endpoint.

According to the company, ITI-007 was also well tolerated and demonstrated a safety profile that did not differ from placebo. Intra-Cellular indicated that data from the trial will be presented at an upcoming scientific meeting.

Intra-Cellular is also evaluating ITI-007 in a second late-stage study comparing the drug to Johnson & Johnson's Risperdal (risperidone) over six weeks of treatment. Results from the trial of over 500 patients are expected in the second half of 2016.

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