Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a
biopharmaceutical company focused on the development and
commercialization of therapeutics for central nervous system (CNS)
disorders, announces lumateperone presentations at the upcoming
American Psychiatric Association (APA) Annual Meeting to be held
May 1-3, 2021 and will hold a webcast on May 4, 2021.
Dr. McIntyre will describe the lumateperone data presented at
APA in the context of existing medical needs in the treatment mood
disorders including bipolar disorder, and “mixed features” in
bipolar disorder and major depressive disorder.
The presentations at APA highlight lumateperone clinical data in
bipolar depression including in patients who exhibit mixed features
and patients with schizophrenia with co-morbid depression as well
as detailing lumateperone’s favorable safety and tolerability
profile.
The titles and presenters of the poster presentations are as
follows:
Sunday, May 2, 2021, 3:30 p.m.-4:00 p.m. EDT
- “The Safety and Tolerability of
Lumateperone 42 mg for the Treatment of Bipolar Depression: A
Pooled Analysis of 2 Randomized Placebo-Controlled Trials”
(P8-106), presented by Susan L. McElroy, MD.
Monday, May 3, 2021, 1:30 p.m.-2:00 p.m. EDT
- “Adjunctive Lumateperone (ITI-007)
in the Treatment of Bipolar Depression: Results from a Randomized
Clinical Trial” (P11-023), presented by Lakshmi N. Yatham, MBBS,
FRCPC, MRCPsych, MBA.
- “The Efficacy of Lumateperone in
Patients with Bipolar Depression With and Without Mixed Symptoms”
(P11-036), presented by Roger S. McIntyre, MD.
- “Efficacy of Lumateperone (ITI-007)
in Depression Symptoms Associated With Schizophrenia” (P11-087),
presented by Robert E. Davis, PhD.
Investor webcast on, May 4, 2021
The Company will host a webcast on May 4, 2021 at 2:00 p.m. EDT.
The webcast will feature Dr. Roger McIntyre, Professor of
Psychiatry and Pharmacology at the University of Toronto and Head
of the Mood Disorders Psychopharmacology Unit at the University
Health Network, Toronto, Canada.
The live webcast and subsequent replay may be accessed by
visiting the Company's website at www.intracellulartherapies.com.
Please connect to the Company's website at least 5-10 minutes prior
to the live webcast to ensure adequate time for any necessary
software download.
About Bipolar Depression
Bipolar I and Bipolar II disorder are serious, highly prevalent
psychiatric conditions affecting approximately 11 million adults in
the U.S.
These disorders are characterized by recurrent episodes of mania
or hypomania interspersed with episodes of major depression known
as Bipolar depression. Bipolar I and Bipolar II each represent
about half of the overall population of patients with bipolar
disorder.
Bipolar depression is the most common clinical presentation of
bipolar disorder. These episodes tend to last longer, recur more
often, and are associated with a worse prognosis than the
manic/hypomanic episodes. Bipolar depression remains a
significantly underserved medical need, with only a few
FDA-approved treatment options available. These treatments are
commonly associated with tolerability issues.
CAPLYTA® (lumateperone) is under investigation for the treatment
of bipolar disorder. The safety and efficacy for this use has not
been established.
CAPLYTA is indicated for the treatment of schizophrenia in
adults. CAPLYTA is available in 42 mg capsules.
Important Safety Information
Boxed Warning: Elderly patients with dementia-related
psychosis treated with antipsychotic drugs are at an increased risk
of death. CAPLYTA is not approved for the treatment of patients
with dementia-related psychosis.
Contraindications: CAPLYTA is
contraindicated in patients with known hypersensitivity to
lumateperone or any components of CAPLYTA.
Warnings & Precautions: Antipsychotic
drugs have been reported to cause:
- Cerebrovascular Adverse
Reactions in Elderly Patients with Dementia-Related
Psychosis, including stroke and transient ischemic
attack. See BOXED WARNING above.
- Neuroleptic Malignant
Syndrome, which is a potentially fatal reaction. Signs and
symptoms include: hyperpyrexia, muscle rigidity, delirium,
autonomic instability, elevated creatinine phosphokinase,
myoglobinuria (and/or rhabdomyolysis), and acute renal failure.
Manage with immediate discontinuation of CAPLYTA and close
monitoring.
- Tardive Dyskinesia,
a syndrome of potentially irreversible, dyskinetic, and involuntary
movements which may increase as the duration of treatment and total
cumulative dose increases. Discontinue CAPLYTA if clinically
appropriate.
- Metabolic Changes,
including hyperglycemia, diabetes mellitus, dyslipidemia, and
weight gain. Measure weight and assess fasting plasma glucose and
lipids when initiating CAPLYTA and monitor periodically during
long-term treatment.
- Leukopenia, Neutropenia, and
Agranulocytosis (including fatal cases). Perform complete
blood counts in patients with pre-existing low white blood cell
count (WBC) or history of leukopenia or neutropenia. Discontinue
CAPLYTA if clinically significant decline in WBC occurs in absence
of other causative factors.
- Orthostatic Hypotension and
Syncope. Monitor heart rate and blood pressure and warn
patients with known cardiovascular or cerebrovascular disease.
- Falls. CAPLYTA may
cause somnolence, postural hypotension, and motor and/or sensory
instability, which may lead to falls and, consequently, fractures
and other injuries. Assess patients for risk when using
CAPLYTA.
- Seizures. Use
CAPLYTA cautiously in patients with a history of seizures or with
conditions that lower seizure threshold.
- Potential for Cognitive and
Motor Impairment. Advise patients to use caution when
operating machinery or motor vehicles until they are reasonably
certain CAPLYTA therapy does not affect them adversely.
- Body Temperature
Dysregulation. Use CAPLYTA with caution in patients who
may experience conditions that may increase core body temperature
such as strenuous exercise, extreme heat, dehydration, or
concomitant anticholinergics.
- Dysphagia. Use
CAPLYTA with caution in patients at risk for aspiration.
Drug Interactions: Avoid concomitant use
with CYP3A4 inducers and moderate or strong CYP3A4 inhibitors.
Special Populations: Neonates exposed to
antipsychotic drugs during the third trimester of pregnancy are at
risk for extrapyramidal and/or withdrawal symptoms following
delivery. Breastfeeding is not recommended. Avoid use in
patients with moderate or severe hepatic impairment.
Adverse Reactions: The most common adverse
reactions in clinical trials with CAPLYTA vs. placebo were
somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).
Please click here to see full Prescribing Information
including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA is an oral, once daily medicine approved for the
treatment of schizophrenia of adults (42mg/day).
The mechanism of action of CAPLYTA in the treatment of
schizophrenia is unknown. However, the efficacy of CAPLYTA could be
mediated through a combination of antagonist activity at central
serotonin 5-HT2A receptors and postsynaptic antagonist activity at
central dopamine D2 receptors.
CAPLYTA is being developed for the treatment of bipolar
depression, behavioral disturbances in patients with dementia,
including Alzheimer's disease, depression and other
neuropsychiatric and neurological disorders. CAPLYTA has not been
demonstrated to be safe and effective in these other areas.
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.
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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