Intra-Cellular Therapies Announces Presentations on Lumateperone at Two Upcoming Medical Conferences
APA Annual Meeting in New York, May 5-9, 2018
A poster presentation (P5-178) entitled “Lumateperone (ITI-007) for the Treatment of Schizophrenia: Overview of Placebo-Controlled Clinical Trials and an Open-Label Safety Switching Study” is being presented
The presentation highlights key findings from the lumateperone clinical development program in schizophrenia. The schizophrenia efficacy program includes two positive randomized, double-blind, placebo-controlled trials and supportive data from a third study, all three conducted in
A poster presentation (P6-155) entitled “Lumateperone (ITI-007): Results From an Open-Label Safety Switching Study From Standard-of-Care Antipsychotic Therapy in Patients With Schizophrenia” is being presented
The poster presents additional information from the ITI-007-303 lumateperone open-label safety switching study. This study extends our understanding of the safety and effectiveness of lumateperone. Patients (N=302) with stable symptoms of schizophrenia were switched from standard-of-care antipsychotic medications to lumateperone with no dose titration required for a 6-week treatment duration, then switched back to standard-of-care and assessed again after 2 weeks. Consistent with and extending previous data from our studies in patients with acutely exacerbated schizophrenia, lumateperone (ITI-007 60 mg) was generally well-tolerated with a favorable safety profile. Statistically significant improvements from standard-of-care baseline were observed in body weight, cardiometabolic and endocrine parameters in patients with stable symptoms of schizophrenia when switched to lumateperone, and several of these safety parameters worsened again when switched back to standard-of-care medication. Additionally, treatment with lumateperone was not associated with the motor or cardiovascular disturbances often associated with other antipsychotic medications. In this study symptoms of schizophrenia did not worsen upon switch to lumateperone. Rather, statistically significant improvement from baseline was observed in the Positive and Negative Syndrome Scale (PANSS) mean total score. In addition, greater improvements were observed in subgroups of patients with comorbid symptoms of depression and those with prominent negative symptoms.
SOBP Annual Meeting in New York, May 10-12, 2018:
A poster presentation (S81) entitled “Unique Pharmacology and Clinical Evidence Supporting the Antidepressant Therapeutic Potential of Lumateperone” is being presented
This presentation highlights preclinical and clinical data that support the use of lumateperone in depressive disorders.
About Intra-Cellular Therapies
About Lumateperone for the Treatment of Schizophrenia
Lumateperone, our lead product candidate, is a first-in-class molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate - three neurotransmitter pathways implicated in severe mental illness. Unlike existing schizophrenia treatments, lumateperone is a dopamine receptor phosphoprotein modulation, or DPPM, acting as a pre-synaptic partial agonist and post-synaptic antagonist at D2 receptors. We believe this mechanism, along with potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation, may contribute to the efficacy of lumateperone across a broad array of symptoms, with improved psychosocial function and favorable tolerability. This compound has the potential to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases.
Our clinical development program for the treatment of schizophrenia with lumateperone includes three large randomized, double-blind, placebo-controlled trials. In two studies, ITI-007 60 mg showed a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale, or PANSS, total score. Across all three studies, lumateperone was found to be well tolerated with a safety profile similar to placebo.
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the therapeutic value, clinical and non-clinical development plans and commercial potential of our drug product candidates; the progress, timing and results of our clinical trials and preclinical studies; our beliefs about the extent to which the results of our clinical trials and preclinical studies to date support new drug application filings for product candidates; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of our drug product candidates; and development efforts and plans under the caption "About Intra-Cellular Therapies." All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to the following: this switching study was an open label study and its efficacy observations may not be replicated in any future controlled trials; any toxicities discovered in our long-term safety study of lumateperone in patients with schizophrenia and nonclinical studies could delay or prevent our filing of an NDA; the
Vice President, Corporate Communications and Investor Relations
Source: Intra-Cellular Therapies Inc.