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 publication of results from the CAPLYTA clinical
trial (ITI-007-303) in adult patients with schizophrenia. The
article, "Safety and tolerability of lumateperone 42 mg: An
open-label antipsychotic switch study in outpatients with stable
schizophrenia" (Correll et al. 2021), was recently published online
in Schizophrenia Research and is available here.
The objective of this 6-week open-label study was to evaluate
the safety and tolerability of CAPLYTA with stable schizophrenia
patients switched from another antipsychotic treatment. The most
common drug-related treatment emergent adverse events during
CAPLYTA treatment were somnolence (6.6%), headache (5.3%) and dry
mouth (5.3%). Reports of EPS were low (1%).
After 6 weeks of CAPLYTA treatment, it was observed that the
mean total cholesterol, low-density lipoprotein (LDL) cholesterol,
body weight and prolactin levels decreased from baseline. At the
conclusion of the treatment period with CAPLYTA, patients were
switched back to their previous or another approved antipsychotic.
In a prespecified secondary safety analysis, conducted 2 weeks
after discontinuing CAPLYTA, it was observed that the mean total
cholesterol, LDL cholesterol, body weight and prolactin levels
increased. In this study, patients’ schizophrenia symptoms remained
stable and did not worsen from baseline.
These data further support the safety, tolerability and
effectiveness of CAPLYTA in patients with schizophrenia and provide
important information to clinicians.
“Weight gain and metabolic side effects or motor disturbances
are leading reasons for healthcare providers to switch
antipsychotics. Scientific results from studies that resemble a
real world clinical setting and published in the medical literature
provide important information for clinicians to make informed
treatment decisions,” said Dr. Christoph Correll, Professor of
Psychiatry and Molecular Medicine at the Zucker School of
Medicine at Hofstra/Northwell, New York. “CAPLYTA is
a valuable addition to the armamentarium to help treat this
challenging mental illness.”
About ITI-007-303
ITI-007-303 is an open label, multicenter study conducted in the
United States to investigate the safety and effectiveness of up to
1 year of treatment with CAPLYTA 42 mg in 301 stable patients with
schizophrenia after switching from previous antipsychotic
medications with no dose titration to CAPLYTA 42 mg. The study was
conducted in 2 parts.
In Part 1, patients were eligible for participation if they had
stable psychopathology and were able to be treated on an outpatient
basis after Day 5. Entering the screening period on an existing
antipsychotic was not a requirement of the study; therefore,
medication history could not always be verified.
Patients meeting entry criteria were required to discontinue
previous antipsychotics, tapering as appropriate, prior to starting
CAPLYTA 42 mg with no dose titration. The primary objective
assessed adverse events (AE), vital signs, laboratory tests, and
extrapyramidal symptoms (EPS). Three hundred and one patients
received CAPLYTA in the study and the 6-week treatment was
completed by 218 (72.2%) of patients. The most common reason for
treatment discontinuation was adverse events (8.9%). At the
conclusion of the treatment period with CAPLYTA, patients were
switched to their previous or another approved antipsychotic and a
follow-up safety assessment was conducted approximately
2 weeks later.
In Part 2 of this study, patients were treated for up to 1 year
and the favorable safety profile was maintained. Data from Part 2
of the study will be published in a separate report.
CAPLYTA® (lumateperone) 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. Reactions have included pruritus, rash (e.g.
allergic dermatitis, papular rash, and generalized rash), and
urticaria.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 (NMS), which is
a potentially fatal reaction. Signs and symptoms include: high
fever, stiff muscles, confusion, changes in breathing, heart rate,
and blood pressure, elevated creatinine phosphokinase,
myoglobinuria (and/or rhabdomyolysis), and acute renal failure.
Patients who experience signs and symptoms of NMS should
immediately contact their doctor or go to the emergency room.
- Tardive Dyskinesia, a syndrome of uncontrolled
body movements in the face, tongue, or other body parts, which may
increase with duration of treatment and total cumulative dose. TD
may not go away, even if CAPLYTA is discontinued. It can also occur
after CAPLYTA is discontinued.
- Metabolic Changes, including hyperglycemia,
diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in
some cases extreme and associated with ketoacidosis, hyperosmolar
coma or death, has been reported in patients treated with
antipsychotics. 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). Complete blood counts should be performed in
patients with pre-existing low white blood cell count (WBC) or
history of leukopenia or neutropenia. CAPLYTA should be
discontinued if clinically significant decline in WBC occurs in
absence of other causative factors.
- Decreased Blood Pressure & Dizziness.
Patients may feel lightheaded, dizzy or faint when they rise too
quickly from a sitting or lying position (orthostatic hypotension).
Heart rate and blood pressure should be monitored and patients
should be warned with known cardiovascular or cerebrovascular
disease. Orthostatic vital signs should be monitored in patients
who are vulnerable to hypotension.
- Falls. CAPLYTA may cause sleepiness or
dizziness and can slow thinking and motor skills, which may lead to
falls and, consequently, fractures and other injuries. Patients
should be assessed for risk when using CAPLYTA.
- Seizures. CAPLYTA should be used cautiously in
patients with a history of seizures or with conditions that lower
seizure threshold.
- Sleepiness and Trouble Concentrating. Patients
should use caution when operating machinery or motor vehicles until
they know how CAPLYTA affects them.
- Body Temperature Dysregulation. CAPLYTA should
be used 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. CAPLYTA should be used with caution
in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used
with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT
inhibitors.
Special Populations: Newborn infants 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. Use of CAPLYTA should
be avoided in patients with moderate or severe liver problems.
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 42mg/day is an oral, once daily atypical antipsychotic
approved for the treatment of schizophrenia of adults. While the
mechanism of action of CAPLYTA in the treatment of schizophrenia is
unknown, 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.
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, whether clinical trial results will
be predictive of future real-world results; our beliefs about the
potential utility of our 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: there
are no guarantees that CAPLYTA will be commercially successful; we
may encounter issues, delays or other challenges in commercializing
CAPLYTA; the COVID-19 pandemic may negatively impact our commercial
plans and sales for CAPLYTA; the COVID-19 pandemic may negatively
impact the conduct of, and the timing of enrollment, completion and
reporting with respect to, our clinical trials; whether CAPLYTA
receives adequate reimbursement from third-party payors; the degree
to which CAPLYTA receives acceptance from patients and physicians
for its approved indication; challenges associated with execution
of our sales activities, which in each case could limit the
potential of our product; results achieved in CAPLYTA in the
treatment of schizophrenia following commercial launch of the
product may be different than observed in clinical trials, and may
vary among patients; any other impacts on our business as a result
of or related to the COVID-19 pandemic; risks associated with our
current and planned clinical trials; we may encounter unexpected
safety or tolerability issues with CAPLYTA following commercial
launch for the treatment of schizophrenia or 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 or in
clinical trials for other indications; 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
Burnsjgrimaldi@burnsmc.com212-213-0006
MEDIA INQUIRIES:Ana FullmerCorporate Media Relations
W2Owcgafullmer@wcgworld.com202-507-0130
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