Intra-Cellular Therapies Presents at the 2017 International College of Neuro-Psychopharmacology (CINP) Thematic Meeting on Tr...
July 20 2017 - 8:30AM
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical
company focused on the development of therapeutics for central
nervous system (CNS) disorders, today announced it had given both
oral (symposium) and poster presentations related to lumateperone
at the 2017 Collegium Internationale Neuro-Psychopharmacologicum
(CINP) Thematic Meeting: Treatment Resistant Depression held
in Prague, July 20-22. The presentations were:
Symposium presentation entitled “ITI-007 – a novel antipsychotic
drug with potent SERT inhibitory action and D1-dependent indirect
modulation of glutamate – Clinical profile.” presented Thursday,
July 20, 2017 during Symposium 2 — Atypical antipsychotic
augmentation in TRD: an update.
Poster Presentation P026 entitled “Lumateperone Uniquely
Enhances Glutamatergic Neurotransmission through activation
of both NMDA and AMPA channels via a dopamine D1
receptor-dependent mechanism: Implications for Treatment of Mood
Disorders.” presented on Thursday, June 20 and Friday, July 21,
2017 during the Poster Sessions.
Poster Presentation P028 entitled: “Unique Pharmacology and
Clinical Evidence Supporting the Antidepressant Therapeutic
Potential of Lumateperone” presented on Thursday, June 20 and
Friday, July 21, 2017 during the Poster Sessions.
In presentations at the CINP meeting, the Company presented an
update on the late stage clinical program in schizophrenia with its
most advanced agent lumateperone. In addition to summarizing the
two, positive, large efficacy studies conducted to date, more
recently generated nonclinical data further characterizing the
unique pharmacology of this first-in-class investigational agent
were summarized supporting the unique mechanism of action of
lumateperone at the dopamine D2 receptor, as a pre-synaptic D2
partial agonist and a post-synaptic D2 antagonist. This novel
finding is believed to form the basis of efficient modulation of
dopamine, providing antipsychotic efficacy at relatively low
striatal D2 receptor occupancy without the motoric disturbances
associated with many current therapies. Further, the Company shared
recent data, demonstrating that lumateperone, as a standalone
agent, indirectly enhances glutamatergic neurotransmission through
both AMPA and NMDA channels in the prefrontal cortex, mechanisms
thought to predict potent and rapid antidepressant effects. This
finding had not previously been observed with an antipsychotic
agent in the absence of antidepressant augmentation. These effects
on glutamate neurotransmission are dependent on the ability of
lumateperone to increase D1 receptor activity and inhibit SERT
activity, unique amongst current antipsychotic drugs. Additionally,
the Company presented data demonstrating that lumateperone,
consistent with a rapid acting antidepressant effect, increases
protein phosphorylation of key proteins in the mTOR pathway. These
findings, in addition to the potent SERT activity previously
described with lumateperone, suggest the potential for lumateperone
to exhibit potent and rapid antidepressant effects in patients
suffering from a range of mood disorders. With over 1500
individuals exposed to date in clinical trials, lumateperone has
been well-tolerated with a safety profile similar to placebo. In
addition to schizophrenia, lumateperone is in Phase III clinical
development as a treatment for bipolar depression and agitation of
dementia, including Alzheimer’s disease.
About Intra-Cellular Therapies
Intra-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
platform and other proprietary chemistry platforms to develop drugs
for the treatment of CNS and other disorders.
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, 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 Relations
646-440-9333
Burns McClellan, Inc.
Lisa Burns
Justin Jackson (Media)
jjackson@burnsmc.com
212-213-0006
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