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 presentations of lumateperone including the results from
Phase 3 adjunctive Major Depressive Disorder (MDD), Study 501 at
the 37th European College of Neuropsychopharmacology (ECNP)
Congress being held September 21 - 24, 2024 in Milan, Italy.
“We are very pleased to present additional lumateperone data
across depressive disorders including remarkable positive results
from Study 501 evaluating lumateperone 42 mg as an adjunctive
therapy to antidepressants for the treatment of MDD at ECNP. The
robust efficacy demonstrated by lumateperone, coupled with its
favorable safety and tolerability profile, position CAPLYTA to
become an important medicine for the treatment of MDD,” said
Dr. Suresh Durgam, Executive Vice President and Chief Medical
Officer of Intra-Cellular Therapies. “We are on track to
submit our lumateperone sNDA for the adjunctive treatment of MDD
including the results of Studies 501 and 502 later this year.”
Details of the presentations are as follows:
Study 501 Presentations
Oral presentation: “Adjunctive Lumateperone
Significantly Improves Symptoms of Major Depressive Disorder:
Topline Results From a Randomised, Double-Blind, Placebo-Controlled
Phase 3 Trial.” Monday, September 23, 15:00 - 16:20 CEST.
P2127: “Lumateperone as
Adjunctive Therapy in Patients With Major Depressive Disorder:
Results From a Randomised, Double-blind, Phase 3 Trial.” Monday,
September 23 12:35 - 14:00 CEST.
Study 403 Presentations
P2113: “Lumateperone in the Treatment of
Patients With Major Depressive Disorder and Bipolar Disorder With
Anxious Distress and Mixed Features.” Monday, September 23 12:35 -
14:00 CEST.
P2096: “Lumateperone in the
Treatment of Major Depressive Disorder and Bipolar Depression With
Mixed Features: Efficacy Across Symptoms.” Monday, September 23
12:35 - 14:00 CEST.
In Study 501, lumateperone met the primary endpoint of change
from baseline at Week 6 on the Montgomery Asberg Depression Rating
Scale (MADRS) total score versus placebo with a 4.9-point reduction
(p<0.0001; Cohen’s d effect size (ES)= 0.61). Statistically
significant reductions in depressive symptoms as measured by the
MADRS were seen at the earliest time point tested, Week 1, and
these improvements continued throughout the course of the trial.
Lumateperone also met the key secondary endpoint of change from
baseline on the clinician-rated Clinical Global Impression Scale
for Severity of Illness (CGI-S) (p < 0.0001; ES: 0.67).
On a patient-reported measure, the Quick Inventory of Depressive
Symptomatology Self Report scale (QIDS), patients reported robust
reduction in their depressive symptoms (p <0.0001). Adverse
events were similar to those seen in prior studies of lumateperone
as a treatment for bipolar depression and schizophrenia. Mean
changes in key metabolic parameters including glucose, insulin,
triglycerides, and total, LDL and HDL cholesterol were similar
between lumateperone and placebo. Importantly, mean changes in
weight were also similar to placebo.
In an additional, similarly-designed trial, Study 502,
lumateperone 42 mg plus an antidepressant met primary and key
secondary efficacy endpoints (MADRS Total Score [LSMD vs
placebo=−4.5; ES= 0.56; P<0.0001] and CGI-S score [LSMD vs
placebo=−0.5; ES= 0.51; P<0.0001]) and was generally safe and
well tolerated in patients with MDD with inadequate antidepressant
response. Details of Study 502 will be presented at upcoming
conferences.
Study 403 presentations highlight important analyses of
lumateperone’s double-blind placebo-controlled study in patients
with either MDD or bipolar depression exhibiting mixed
features.
Poster #2113 presents a post-hoc analysis of Study 403
evaluating lumateperone’s efficacy in the prespecified patient
population with MDD or bipolar depression with mixed features who
also met the Diagnostic and Statistical Manual of Mental Disorders,
5th edition (DSM-5) criteria for anxious distress.
In this analysis, lumateperone significantly improved depression
symptoms and severity (MADRS Total score and CGI-S score) compared
with placebo. Lumateperone also significantly improved MADRS inner
tension single-item score in patients with co-morbid anxious
distress. Both anxious distress and mixed features are specified in
the DSM-5 and are common in patients with major depressive episodes
associated with MDD and bipolar disorder. Patients with these
specifiers have more severe symptoms, more comorbidities, increased
suicide risk, and/or poorer treatment response than patients
without these specifiers.
Poster #2096 presents a post-hoc analysis of Study 403
individual MADRS items. Treatment with lumateperone significantly
improved a broad range of depression symptoms across individual
MADRS items.
About Major Depressive Disorder
Major Depressive Disorder (MDD) is a common mood disorder in the
U.S. affecting an estimated 21 million adults each year. Depressive
disorders are the number two cause of years lived with disability
in the world. Symptoms include sadness, hopelessness, helplessness,
feelings of guilt, irritability, loss of interest in formerly
pleasurable activities, cognitive impairment, disturbed sleep
patterns, and suicide ideation or behavior. MDD can cause severe
functional impairment, adversely affecting interpersonal
relationships, and may impact quality of life. Approximately
two-thirds of patients with depression fail to achieve remission
with first-line treatment.
CAPLYTA® (lumateperone) is indicated in adults for the treatment
of schizophrenia and for the treatment of depressive episodes
associated with bipolar I or II disorder (bipolar depression) as
monotherapy and as adjunctive therapy with lithium or
valproate.
Important Safety Information
Boxed Warnings:
- 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.
- Antidepressants increased the risk of suicidal thoughts
and behaviors in pediatric and young adults in short-term studies.
All antidepressant-treated patients should be closely monitored for
clinical worsening, and for emergence of suicidal thoughts and
behaviors. The safety and effectiveness of CAPLYTA have not been
established in pediatric patients.
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.
- Potential for Cognitive and Motor Impairment.
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. Dose reduction is recommended for concomitant
use with strong CYP3A4 inhibitors or moderate CYP3A4
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. Dose reduction is recommended for patients with moderate
or severe hepatic impairment.
Adverse Reactions: The most common adverse
reactions in clinical trials with CAPLYTA vs. placebo were
somnolence/sedation, dizziness, nausea, and dry mouth.
CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.
Please click here to see full Prescribing Information
including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA 42 mg is an oral, once daily atypical antipsychotic
approved in adults for the treatment of schizophrenia and the
treatment of depressive episodes associated with bipolar I or II
disorder (bipolar depression) as monotherapy and as adjunctive
therapy with lithium or valproate. While the mechanism of action of
CAPLYTA 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.
Lumateperone is being studied for the treatment of major
depressive disorder, and other psychiatric and neurological
disorders. Lumateperone is not FDA-approved for these
disorders.
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, our expectations regarding the
commercialization of CAPLYTA; our plans to conduct clinical or
non-clinical trials and the timing of developments with respect to
those trials, including enrollment, initiation or completion of
clinical conduct, or the availability or reporting of results;
plans to make regulatory submissions to the FDA and the timing of
such submissions; whether clinical trial results will be predictive
of future real-world results; whether CAPLYTA will serve an unmet
need; the goals of our development programs; 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; whether CAPLYTA receives adequate reimbursement from
third-party payors; the degree to which CAPLYTA receives acceptance
from patients and physicians for its approved indications;
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 and bipolar
depression following commercial launch of the product may be
different than observed in clinical trials, and may vary among
patients; challenges associated with supply and manufacturing
activities, which in each case could limit our sales and the
availability of our product; 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 bipolar depression or in ongoing
or future trials and other development activities; there is no
guarantee that a generic equivalent of CAPLYTA will not be approved
and enter the market before the expiration of our patents; there is
no guarantee that our planned sNDA for the treatment of MDD will be
submitted or approved, if at all, on the timeline that we expect;
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; impacts on our business, including on the
commercialization of CAPLYTA and our clinical trials, as a result
of the COVID-19 pandemic, the conflicts in Ukraine, Russia and the
Middle East, global economic uncertainty, inflation, higher
interest rates or market disruptions; 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.Cameron
Radinoviccradinovic@burnsmc.com646-930-4406
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