Intra-Cellular Therapies has said a Phase Ib/II clinical trial has shown that investigational drug ITI-007 is safe and well-tolerated in patients with stabilised schizophrenia.
Clinical signs consistent with antipsychotic and antidepressant efficacy were also observed in the study, including a reduction in the total Positive and Negative Syndrome Scale and the Calgary Depression Scale for Schizophrenia.
The study evaluated the safety, tolerability and pharmacokinetic profile of ITI-007 in 45 patients with stable schizophrenia.
Exploratory endpoints included clinical assessments to measure the symptoms of schizophrenia and symptoms of depression, both of which exhibited improvements after ITI-007 administration.
Pharmacokinetic profiles of ITI-007 suggest a once-a-day treatment regimen will be enough to achieve significant efficacy in the patient population.
The results also provided a basis for choosing an active dose range for future efficacy trials of ITI-007 as a treatment of acutely exacerbated schizophrenia.
ITI-007 is also being developed for the treatment of other neuropsychiatric diseases such as bipolar disorder, major depressive disorder and sleep maintenance insomnia.
