NEW YORK, Sept. 28, 2018 — Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the Company has completed the rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumateperone, a once-daily, oral investigational medicine with a novel mechanism of action for the treatment of schizophrenia. The NDA submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia.
“Our first NDA submission represents a significant milestone for the Company and the development of lumateperone, which we believe has the potential to be an important advance in the treatment of schizophrenia. We look forward to the prospect of working with the FDA to bring lumateperone to patients living with this debilitating disease as quickly as possible,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with Alzheimer’s disease, depression, and other neuropsychiatric and neurological disorders. The Company is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. The lead molecule in the Company’s PDE1 portfolio, ITI-214, is in development for the treatment of Parkinson’s disease and heart failure.
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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 modulator (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.
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 data supporting the NDA for lumateperone for the treatment of schizophrenia; potential approval by the FDA of the NDA for lumateperone for the treatment of schizophrenia; our belief that lumateperone has the potential to represent an important advance in the treatment of patients with schizophrenia; the potential benefits of Fast Track designation to facilitate or accelerate the regulatory approval of lumateperone for the treatment of schizophrenia; the potential for the lumateperone compound to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases; 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: whether the NDA for lumateperone for the treatment of schizophrenia will be accepted and approved by the FDA; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with lumateperone in ongoing or future trials and other development activities; 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 proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. 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 646-440-9333 MEDIA INQUIRIES: Patrick Ryan, Esq. Corporate Media Relations, WCG World [email protected]