Intra-Cellular Therapies Presents Data on Mechanism of Action of Lumateperone and ITI-214 at the 2017 Society for Neuroscienc...
November 14 2017 - 8:00AM
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical
company focused on the development of therapeutics for central
nervous system (CNS) disorders, today announced poster
presentations related to its lumateperone and ITI-214 development
programs at the 2017 Society for Neuroscience Annual Meeting (SfN)
being held in Washington DC, November 11-14.
Poster # 511.18 entitled “Lumateperone (ITI-007) is a
postsynaptic D2 receptor antagonist” is being presented Tuesday
November 14, 2017 during the Poster Session – Striatal Circuits in
Behavior.
In this poster we present preclinical data detailing the unique
mechanism of action of lumateperone at the D2 receptor, further
characterizing the pharmacology of this first-in-class
investigational agent. This finding strengthens our understanding
of the unique mechanism of action of lumateperone as a pre-synaptic
D2 partial agonist and a post-synaptic D2 antagonist, which is
believed to form the basis of efficient modulation of dopamine,
providing antipsychotic efficacy at relatively low striatal D2
receptor occupancy without the motor disturbances associated with
many current antipsychotic therapies.
Poster #564.23 entitled “ITI-214, a novel and selective
phosphodiesterase 1 inhibitor, reverses LPS-induced inflammatory
responses in BV2 cells and in mice” is being presented Tuesday
November 14, 2017 during the Poster Session– Microglia in
Disease.
In this presentation we describe preclinical data showing the
importance of ITI-214 and inhibition of PDE1 in reducing
neuroinflammation, and in regulating microglial function, the
primary immune cells of the CNS. Specifically, ITI-214 suppressed
proinflammatory responses in vivo in a mouse model of inflammation
and in vitro in mouse microglial cells. Reflecting the dual
roles for the molecular target of ITI-214, PDE1, both
cGMP-dependent and cAMP-dependent intracellular pathways were
involved in the anti-inflammatory response. These data
support a unique role for ITI-214 in regulating microglial
responses and its use in treating neuroinflammation.
Excessive inflammation has been implicated in neurodegenerative
diseases, where neurons are lost and not replaced. Microglia,
the resident immune cells in the nervous system, express both
anti-inflammatory and proinflammatory phenotypes, and understanding
the mechanisms that control the expression of these phenotypes may
provide new avenues for therapeutic intervention in
neurodegenerative disease.
About Intra-Cellular TherapiesIntra-Cellular
Therapies is developing novel drugs for the treatment of
neuropsychiatric and neurodegenerative diseases and diseases of the
elderly, including Parkinson's 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 dementia, including
Alzheimer's disease, depression and other neuropsychiatric and
neurological disorders. Lumateperone, a first-in-class molecule, is
in Phase 3 clinical development for the treatment of schizophrenia,
bipolar depression and agitation associated with dementia,
including Alzheimer's disease. 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 symptoms associated
with Parkinson's disease.
Forward-Looking StatementsThis 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, our clinical and non-clinical development plans; 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 lumateperone; 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: our
current and planned clinical trials, other studies for
lumateperone, 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 proposals with respect
to the regulatory path for our product candidates may not be
acceptable to the FDA; 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
Relations646-440-9333
Burns McClellan, Inc.Lisa BurnsJustin Jackson
(Media)jjackson@burnsmc.com212-213-0006
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