Intra-Cellular Therapies Announces Expansion of its Pipeline with the Introduction of a New Molecular Entity, ITI-1284
February 24 2021 - 7:30AM
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a
biopharmaceutical company focused on the development and
commercialization of therapeutics for central nervous system (CNS)
disorders, today announced the expansion of its pipeline with
ITI-1284 ODT-SL. ITI-1284 is a deuterated form of lumateperone, a
new molecular entity formulated as an oral disintegrating tablet
for sublingual administration. Following recent completion of its
Phase 1 program, the Company plans to develop ITI-1284 ODT-SL for
the treatment of behavioral disturbances in patients with dementia,
the treatment of dementia-related psychosis and the treatment of
certain depressive disorders in the elderly.
ITI-1284 ODT-SL is formulated as an oral solid dosage form that
dissolves almost instantly when placed under the tongue, allowing
for ease of use in the elderly and may be particularly beneficial
for patients who have difficulty swallowing conventional tablets.
ITI-1284 ODT-SL has been developed in collaboration with Catalent
using its proprietary Zydis® ODT (orally disintegrating tablet)
fast-dissolving formulation.
Our recently completed Phase I program found that ITI-1284
ODT-SL was rapidly absorbed into the systemic circulation, was
metabolically stable, and resulted in high systemic exposure. Our
Phase 1 single and multiple ascending dose studies in healthy
volunteers and healthy elderly volunteers (> than 65 years of
age) evaluated the safety, tolerability and pharmacokinetics of
ITI-1284. In these studies, there were no reported serious adverse
events in either age group. In the elderly cohort, reported adverse
events were infrequent with the most common adverse event being
transient dry mouth (mild).
Based on these studies, the Company plans to initiate Phase 2
studies evaluating ITI-1284 ODT-SL for the treatment of behavioral
disturbances in dementia, dementia-related psychosis, and certain
depressive disorders in the elderly.
About ITI-1284
ITI-1284 is a deuterated form of lumateperone where
carbon-deuterium bonds strategically replace carbon-hydrogen bonds.
ITI-1284 has high affinity for serotonin 5-HT2A receptors and
moderate affinity for dopamine D2 and D1 receptors, and the
serotonin transporter.
ITI- 1284 is an investigational agent and has not been approved
for use for any indication.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company
founded on Nobel prize-winning research that allows us to
understand how therapies affect the inner-workings of cells in the
body. The company leverages this intracellular approach to develop
innovative treatments for people living with complex psychiatric
and neurologic diseases. For more information, please
visit www.intracellulartherapies.com.
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 therapeutic value, clinical and
non-clinical development plans and commercial potential of our drug
product candidates; 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 product
candidates; 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 or other studies for our 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; the COVID-19 pandemic may negatively impact the conduct
of, and the timing of enrollment, completion and reporting with
respect to, our clinical trials; any other impacts on our business
as a result of or related to the COVID-19 pandemic; 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
Burnsjgrimaldi@burnsmc.com212-213-0006
MEDIA INQUIRIES:Ana FullmerCorporate Media Relations
W2Owcgafullmer@wcgworld.com202-507-0130
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