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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataITI-007 is also being developed for the treatment of other neuropsychiatric diseases such as bipolar disorder, major depressive disorder and sleep maintenance insomnia.
