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Intra-Cellular Therapies Announces Enrollment of First Patient in Phase 3 Trial of ITI-007 for the Treatment of Schizophrenia

NEW YORK, Nov. 25, 2014 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, announced today that the first patient has been enrolled in the ITI-007-301 Phase 3 trial, a randomized, double-blind, placebo-controlled trial designed to demonstrate the efficacy of ITI-007 for the treatment of schizophrenia. The Company anticipates top-line results from this trial could be available as early as the fourth quarter of 2015.

The Company expects to initiate a second ITI-007 Phase 3 trial in schizophrenia, designated as the ITI-007-302 trial, in the first half of 2015. In December 2013, the Company announced positive results from a Phase 2 trial in which ITI-007 exhibited antipsychotic efficacy with a favorable safety profile in patients with schizophrenia.

"ITI-007 is a first-in-class antipsychotic investigational new drug with a novel mechanism of action," said Dr. Sharon Mates, Chief Executive Officer and Chairman. "Starting the enrollment of patients in our first Phase 3 trial of ITI-007 for the treatment of schizophrenia marks an important milestone for the Company and for patients who eagerly await safe and effective alternatives to currently available treatment options. We believe ITI-007 has the potential to broadly address multiple symptom domains, including positive symptoms, negative symptoms and depressive symptoms without debilitating motor side effects or metabolic syndrome commonly associated with some antipsychotic drugs."

About the ITI-007-301 Phase 3 Trial

The ITI-007-301 clinical trial is a randomized, double-blind, placebo-controlled Phase 3 trial designed to determine the safety and efficacy of ITI-007 for the treatment of schizophrenia. Over 400 patients with an acutely exacerbated episode of schizophrenia are planned to be randomized to receive one of three treatments: 60 mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio. Patients will receive study treatment orally once daily in the morning for 28 days. The primary endpoint for this clinical trial is change from baseline to Day 28 on the Positive and Negative Syndrome Scale (PANSS) total score. The PANSS is a well-validated 30-item rating scale that measures the ability of a drug to reduce schizophrenia symptom severity (Kay et al., 1987, Schizophrenia Bulletin 13:261-276). The PANSS measures positive symptoms, such as delusions, suspiciousness, and hallucinations; negative symptoms, such as blunted affect, social and emotional withdrawal, and stereotyped thinking; and general psychopathology, such as anxiety, tension, depression, and active social avoidance. Secondary endpoints include subscales of the PANSS and other measures to highlight key differentiating features of ITI-007. Safety and tolerability also will be assessed.

About ITI-007

ITI-007 is our lead drug development candidate, whose mechanisms of action, we believe, have the potential to yield a first-in-class antipsychotic therapy. In our pre-clinical and clinical trials to date, ITI-007 combines potent serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation (DPPM), glutamatergic modulation and serotonin reuptake inhibition into a single drug candidate for the treatment of acute and residual schizophrenia. At dopamine D2 receptors, ITI-007 has been demonstrated to have dual properties and to act as both a post-synaptic antagonist and a pre-synaptic partial agonist. ITI-007 has also been demonstrated to stimulate phosphorylation of glutamatergic NMDA NR2B, or GluN2B, receptors in a mesolimbic specific manner. We believe that this regional selectivity in brain areas thought to mediate the efficacy of antipsychotic drugs, together with serotonergic, glutamatergic, and dopaminergic interactions, may result in antipsychotic efficacy for positive, negative, affective and cognitive symptoms associated with schizophrenia. The serotonin reuptake inhibition could allow for antidepressant activity for the treatment of schizoaffective disorder, co-morbid depression, and/or as a stand-alone treatment for major depressive disorder. We believe ITI-007 may also be useful for the treatment of bipolar disorder and other psychiatric and neurodegenerative disorders, particularly behavioral disturbances associated with dementia, autism and other CNS diseases.

About Schizophrenia

Schizophrenia is a disabling and chronic mental illness affecting over 1% of the world's population. Schizophrenia is characterized by multiple symptoms during an acute phase of the disorder that can include so-called "positive" symptoms, such as hearing voices, grandiose beliefs and suspiciousness or paranoia. These symptoms can be accompanied by additional, harder-to-treat symptoms, such as social withdrawal, blunted emotional response and speech deficits, collectively referred to as "negative" symptoms, difficulty concentrating and disorganized thoughts, or cognitive impairment, depression and insomnia. Such residual symptoms often persist even after the acute positive symptoms subside, and contribute substantially to the social and employment disability associated with schizophrenia. Current antipsychotic medications provide some relief for the symptoms associated with the acute phase of the disorder, but they do not effectively treat the residual phase symptoms associated with chronic schizophrenia. Currently available medications used to treat acute schizophrenia are limited in their use due to side effects that can include movement disorders, weight gain, metabolic disturbances, and cardiovascular disorders. There is an unmet medical need for new therapies that have improved side effect and efficacy profiles.

About Intra-Cellular Therapies

Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative disease and other disorders of the central nervous system. The Company is developing its lead drug candidate, ITI-007, for the treatment of schizophrenia, behavioral disturbances in dementia, bipolar disorder and other neuropsychiatric and neurological disorders. The Company is also utilizing its phosphodiesterase platform and other proprietary chemistry platforms to develop drugs for the treatment of cognitive deficits in schizophrenia and other CNS disorders. In addition, the Company is developing inhibitors against other targets for CNS indications such as Alzheimer's disease, Parkinson's disease and depression and non-CNS indications such as cardiovascular disease.

Forward-Looking Statements

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 progress and timing of our drug discovery and development programs; our beliefs about the potential uses and benefits of ITI-007; and our research and development efforts and plans under the caption "About Intra-Cellular Therapies, Inc." 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: our current and planned clinical trials for ITI-007 and our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our reliance on collaborative partners and other third-parties for development and commercialization of our product candidates; and the other risk factors discussed under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2013 filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our periodic and current reports. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.

CONTACT: Intra-Cellular Therapies, Inc. Juan Sanchez, M.D. Vice President, Corporate Communications and Investor Relations 212-923-3344 Burns McClellan, Inc. Lisa Burns/Angeli Kolhatkar (Investors) Justin Jackson (Media) jjackson@burnsmc.com 212-213-0006

Source:Intra-Cellular Therapies, Inc.