Intra-Cellular Therapies ITI-007 Phase Ib/II clinical trial for schizophrenia meets primary endpoint

Jul 30 2010

Intra-Cellular Therapies, Inc. today announced the results from a Phase Ib/II clinical trial in patients with schizophrenia with ITI-007, the Company's unique, investigational new drug for the treatment of schizophrenia.  The trial met its primary endpoint demonstrating that ITI-007 was safe and well-tolerated in patients with stabilized schizophrenia.  In addition, several exploratory endpoints were evaluated. Treatment with ITI-007 yielded important clinical signs consistent with antipsychotic and antidepressant efficacy including a reduction in the total Positive and Negative Syndrome Scale (PANSS) and the Calgary Depression Scale for Schizophrenia (CDSS). These results establish a firm basis for selecting an active dose range for future efficacy trials of ITI-007 in the treatment of patients with acutely exacerbated schizophrenia.

"New and safer drugs are needed to treat the broad spectrum of symptoms seen in patients with schizophrenia.  ITI-007 represents an exciting new drug with the potential to treat many of the symptoms that accompany schizophrenia, some of which have been previously unaddressed," said Carol Tamminga, M.D., Professor of Psychiatry at the University of Texas, UT Southwestern Medical Center and leader in the field of schizophrenia research.  "Given the novel pharmacology of ITI-007, the potential exists to treat different symptoms by simple dose adjustments as the symptoms of schizophrenia wax and wane over time. Future clinical trials will be designed to extend these initial findings and to demonstrate the unique characteristics of ITI-007."

"We are pleased to have demonstrated such an excellent safety profile of ITI-007 in our target patient population.  The demonstration of clinical signals across a broad spectrum of exploratory efficacy measures is also encouraging, especially considering that these patients had clinically stable symptoms at study entry," stated Sharon Mates, Chief Executive Officer of Intra-Cellular Therapies.  "We believe that the favorable clinical profile is consistent with ITI-007's unique pharmacology."

SOURCE Intra-Cellular Therapies, Inc.