Additional phase III data shows ITI 007 improves symptoms of schizophrenia- Intra-Cellular Therapies

Intra-Cellular Therapies has announced additional data from the first Phase III clinical trial of ITI-007 for the treatment of patients with schizophrenia (ITI-007-301) and the ITI-007 Positron Emission Tomography (PET) study in patients with schizophrenia. ITI-007 60 mg improved symptoms of schizophrenia and met the primary endpoint demonstrating statistically significant superiority over placebo at Day 28 as measured by the Positive and Negative Syndrome Scale (PANSS) total score. The 40 mg dose approximated the trajectory of improvement seen with the 60 mg dose, but the effect with 40 mg did not reach statistical significance on the PANSS total score. Both the 60 mg and 40 mg doses of ITI-007 significantly reduced the PANSS positive symptom subscale score versus placebo at study endpoint and at earlier time points. ITI-007 60 mg met the key secondary endpoint demonstrating statistically significant improvement on the Clinical Global Impression scale for Severity of Illness (CGI-S).

ITI-007 40 mg also demonstrated a statistically significant improvement versus placebo on the CGI-S. The CGI-S is a well-established and clinically useful rating tool which provides a clinician's view of the patient's global level of illness severity. Moreover, ITI-007 significantly improved social function as evidenced by improvements in the PANSS-derived Prosocial Factor and the Personal and Social Performance Scale. Data were presented at the 54th annual meeting of the American College of Neuropsychopharmacology.