Intra-Cellular: ITI-007 60 Mg Meets Primary And Key Secondary Endpoints

(RTTNews) - Intra-Cellular Therapies, Inc. (ITCI) announced positive results from the first Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia. The company said its once-daily ITI-007 60 mg met the primary endpoint in the trial and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4. ITI-007 60 mg also met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scale for Severity of Illness.

Intra-Cellular Therapies said the findings confirm the positive results demonstrated by ITI-007 60 mg in the company's Phase 2 study. ITI-007 had a favorable safety and tolerability profile consistent with previous studies.

The company also announced top-line data from a separate clinical study using positron emission tomography in patients with schizophrenia. The company said ITI-007 demonstrated antipsychotic effect at relatively low striatal D2 receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs.