Shares in Intra-Cellular Therapies fell as much as 68 percent Wednesday after the company revealed that the investigational schizophrenia drug ITI-007 failed to achieve the primary endpoint of a Phase III study. The drugmaker indicated that the therapy failed to separate from placebo at either tested dose due to an unexpectedly large placebo response.
"Based on the strength of the clinical data generated in this programme to date…we continue to believe ITI-007 will be an important treatment for patients suffering from schizophrenia," commented Intra-Cellular CEO Sharon Mates, adding "we remain committed to the development of ITI-007 for the treatment of schizophrenia, bipolar depression, agitation associated with dementia, including Alzheimer's disease and other neuropsychiatric indications."
In the study, 696 patients with schizophrenia were randomised to treatment with ITI-007, at one of two doses, risperidone as the active control or placebo once daily for six weeks. The primary endpoint of the study was the change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score.
Intra-Cellular noted that the data showed that the changes in the PANSS total score were -15.0 points and -14.6 points in the ITI-007 lower and higher dose groups, respectively, compared to -15.1 points for placebo. Conversely, the mean reduction in the score in the risperidone group was -20.5 points.
Meanwhile, in another late-stage trial of patients with schizophrenia, study results unveiled last year showed that ITI-007 was associated with significant antipsychotic efficacy versus placebo as assessed using the PANSS total score. For related analysis, see Spotlight On: Intra-Cellular sees ‘007 as the agent with the golden gun for psychiatric disorders.
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