Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical
company focused on the development and commercialization of
therapeutics for central nervous system (CNS) disorders, announced
the publication of results from its CAPLYTA (lumateperone) clinical
trial (ITI-007-301) in adult patients with schizophrenia. The
article, "Efficacy and Safety of Lumateperone for Treatment of
Schizophrenia: A Randomized Clinical Trial" (Correll et al. 2020),
was recently published online in JAMA Psychiatry and is available
here.
In this trial, CAPLYTA 42 mg met the primary endpoint and
demonstrated antipsychotic efficacy with statistically significant
superiority over placebo at Week 4 as measured by the change from
baseline on the Positive and Negative Syndrome Scale (PANSS) total
score (drug-placebo difference = -4.2 points). CAPLYTA 42 mg also
met the key secondary endpoint of statistically significant
improvement on the Clinical Global Impression Scale for Severity of
Illness. CAPLYTA 42 mg showed significant antipsychotic efficacy as
early as week 1, which was maintained at every time point
throughout the study.
The most commonly reported adverse events occurring for CAPLYTA
42 mg in ≥5% of patients and >2 times the rate in the placebo
group were somnolence (CAPLYTA 42 mg, 17.3% vs placebo, 4.0%),
sedation (12.7% vs 5.4%), fatigue (5.3% vs 1.3%), and constipation
(6.7% vs 2.7%).
No significant differences were observed compared to placebo on
metabolic parameters, including weight, cholesterol, triglycerides,
glucose and insulin, or on prolactin levels. No extrapyramidal
symptoms (EPS)–related TEAEs occurred in 5% or more of patients in
any treatment arm.
“Treatment with CAPLYTA 42 mg significantly improved symptoms in
patients with acute exacerbation of schizophrenia with a favorable
tolerability profile,” said Dr. Christoph Correll, Professor
of Psychiatry and Molecular Medicine at the Zucker School of
Medicine at Hofstra/Northwell, New York. “CAPLYTA
represents an important addition to the treatment options of
healthcare providers managing this heterogeneous mental
condition.”
Intra-Cellular Therapies is also presenting today additional
analyses of Study ITI-007-301 in a poster at the International
Society for CNS Clinical Trials and Methodologies (ISCTM) Annual
Scientific Meeting that further demonstrate the strength of the
Study 301 results.
This poster presents a post-hoc sensitivity analysis of Study
ITI-007-301 that assesses the sensitivity of the prospective
Mixed-effect Model for Repeated Measures (MMRM) based analysis,
which assumes missing data as missing-at-random (MAR), under the
alternative assumption that missing data were missing-not-at-random
(MNAR). There was a higher rate of early discontinuations due to
lack of efficacy in the placebo group compared with the
lumateperone-treated group, suggesting that the MAR assumption that
underlies the MMRM analysis may result in an underestimation of the
drug-placebo difference by at least 32%. Using 3 other
appropriate methods for dealing with imbalances in discontinuations
due to lack of efficacy, lumateperone 42 mg was found to have
substantially greater benefit compared with placebo than that
obtained using the primary MMRM analysis, with drug-placebo
differences of -6.2, -6.5, and -7.3 points on the PANSS in these
analyses compared with -4.2 points in the primary analysis.
Results from these additional sensitivity analyses confirm the
efficacy of lumateperone 42 mg compared with placebo in Study
‘301.
About the ITI-007-301 Clinical Trial
This randomized, double-blind, fixed-dose, placebo-controlled
Phase 3 inpatient clinical trial was conducted at 12 sites
in the United States with 450 patients randomized (1:1:1)
to receive either CAPLYTA 42 mg or 28 mg or placebo once daily in
the morning for four weeks. Patients were diagnosed with
schizophrenia using DSM-5 criteria and were required to have an
acute exacerbation of psychotic symptoms. The pre-specified primary
efficacy measure was change from baseline at study endpoint (4
weeks) on the centrally rated PANSS total score. The key secondary
endpoint was the centrally rated CGI-S. Trial participants had a
mean PANSS score of 89.8 at baseline, indicative of being markedly
ill. The 28 mg dose is not an approved dose for CAPLYTA.
CAPLYTA (lumateperone) is indicated for the treatment of
schizophrenia in adults.
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 know how CAPLYTA affects them.
- 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 see full Prescribing Information including Boxed
Warning.
About CAPLYTA (lumateperone)
CAPLYTA is an oral, once daily medicine approved for the
treatment of schizophrenia in 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 was approved for the treatment of schizophrenia in
adults by the U.S. Food and Drug
Administration in December 2019.
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 safety and efficacy of CAPLYTA
and our other product candidates; that CAPLYTA represents an
important addition to the treatment options of healthcare
providers; 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 launching or commercializing CAPLYTA; 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 once we have launched the product may be
different than observed in clinical trials, and may vary among
patients; 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; 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.
Contacts:
Intra-Cellular Therapies, Inc.Juan Sanchez, M.D.Vice President,
Corporate Communications and Investor Relations646-440-9333
Burns McClellan, Inc.Lisa
Burnsagray@burnsmc.com 212-213-0006
MEDIA INQUIRIES:
Ana FullmerCorporate Media Relations
W2Owcgafullmer@wcgworld.com202-507-0130
Source: Intra-Cellular Therapies, Inc.
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