Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia
September 28 2018 - 7:00AM
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.
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.
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 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
pryan@wcgworld.com
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