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 positive topline results from its Phase
3 clinical trial (Study 402) evaluating lumateperone as adjunctive
therapy to lithium or valproate in the treatment of major
depressive episodes associated with Bipolar I or Bipolar II
disorder. In Study 402, once daily lumateperone 42 mg met the
primary endpoint for improvement in depression as measured by
change from baseline versus placebo on the MADRS total score
(p=0.0206; effect size = 0.27). Lumateperone 42 mg also met the key
secondary endpoint, the CGI-BP-S Depression Score (p=0.0082; effect
size = 0.31). The lower lumateperone dose, 28 mg, showed a trend
for a dose-related improvement in symptoms of depression but the
results did not reach statistical significance. Lumateperone
demonstrated a favorable safety profile and was generally
well-tolerated in the trial. The most commonly reported adverse
events that were observed at a rate greater than or equal to 5% and
at least twice the rate of placebo were somnolence, dizziness, and
nausea. Rates of akathisia, restlessness, extrapyramidal symptoms,
and changes in weight were similar to placebo. This trial, in
conjunction with our previously reported positive Phase 3
monotherapy study, Study 404, forms the basis for our sNDA for the
treatment of bipolar depression in patients with Bipolar I or II
disorder as monotherapy and adjunctive therapy which we expect to
submit to the FDA in late 2020 or early 2021.
“Our program now has confirmatory evidence of efficacy and a
favorable safety and tolerability profile of lumateperone in
bipolar depression; we look forward to submitting our supplemental
NDA to expand lumateperone’s label to include a second major
neuropsychiatric disorder,” said Dr. Sharon Mates, Chairman and CEO
of Intra-Cellular Therapies. “With this clinical milestone,
lumateperone has shown further potential to benefit patients
suffering from a range of serious mental health conditions in
addition to schizophrenia.”
“Bipolar disorders are serious and complex mental health
conditions that affect millions of people, and depression is the
most common presentation of these disorders. In this study,
lumateperone demonstrated a robust effect, which is particularly
significant considering patients were maintained on lithium or
valproate,” said 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. “Lumateperone is the first treatment to
demonstrate efficacy for bipolar depression as monotherapy and as
adjunctive therapy to mood stabilizers in a study population
including both Bipolar I and Bipolar II patients. This will be
welcome news to the psychiatric community as there is a tremendous
need for improved treatment options.”
About Study 402
Study 402 was conducted globally in five countries including in
the U.S. A total of 529 patients with moderate to severe major
depressive episodes associated with either Bipolar I or Bipolar II
disorder were randomized 1:1:1 to lumateperone 42 mg, 28 mg or
placebo, while being maintained on lithium or valproate as mood
stabilizers.
Lumateperone 42 mg met the primary endpoint by demonstrating a
statistically significant improvement compared to placebo at week 6
(trial endpoint), as measured by change from baseline on the
MADRS total score. In the intent-to-treat (ITT) study population,
the least squares (LS) mean reduction from baseline for
lumateperone 42 mg was 16.9 points, versus 14.5 points for placebo
(LS mean difference = 2.4 points; effect size = 0.27,
p=0.0206).
Lumateperone 42 mg also met the key secondary endpoint of
statistically significant improvement on the CGI-BP-S Depression
Score (p=0.0082; effect size = 0.31).
Lumateperone 28 mg showed a trend for a dose-related improvement
in symptoms of depression. Though not formally tested against
placebo since it did not separate on the primary endpoint,
lumateperone 28 mg demonstrated a statistically significant
improvement versus placebo on the CGI-BP-S.
Lumateperone was generally well-tolerated with a favorable
safety profile in the trial. Adverse events were mostly mild to
moderate and similar to those seen in prior studies in bipolar
depression and schizophrenia, with no new adverse events observed.
These findings provide further evidence supporting lumateperone’s
favorable safety and tolerability profile across different patient
populations.
Conference Call and Webcast Details
Intra-Cellular Therapies will host a live conference call
and webcast today at 8:00 a.m. ET, during which management
will discuss the topline results of Study 402. 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.
Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970)
315-3916 (international) to listen to the live conference call. The
conference ID number for the live call is 2980818. Please dial in
approximately 10 minutes prior to the call.
About Lumateperone
Pharmacodynamics studies have shown lumateperone acts as a
potent antagonist with high binding affinity at serotonin
5-HT2A receptors, as an antagonist with moderate binding
affinity at postsynaptic D2 receptors, an inhibitor of the reuptake
of serotonin transporter (SERT) with moderate biding affinity,
and a partial agonist with moderate affinity at D1 receptors (which
may contribute to the indirect activation of AMPA and NMDA
receptors). These receptors are believed to play an important role
in in schizophrenia, bipolar disorder, depressive disorders and
other neuropsychiatric disorders. In vitro studies have shown
lumateperone has a ~60-fold greater affinity for
5-HT2A receptors compared to D2 receptors.
Lumateperone is being investigated for the treatment of bipolar
depression, depression and other neuropsychiatric and neurological
disorders. Lumateperone is not FDA approved for these disorders.
CAPLYTA 42 mg (lumateperone) is approved by the FDA for
the treatment schizophrenia of adults.
About Bipolar Depression
Bipolar I and Bipolar II disorder are serious, highly prevalent
psychiatric conditions, affecting approximately 6 million adults in
the United States, or about 2.8% of the U.S. population.
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.
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, tolerability and
efficacy of our product candidates; the potential for lumateperone
to receive FDA approval for treatment of bipolar depression in
patients with Bipolar I or II disorder as monotherapy and
adjunctive therapy; our expectation that we will submit an sNDA,
based on Study 402 and Study 404, for the treatment of bipolar
depression in patients with Bipolar I or II disorder as monotherapy
and adjunctive therapy to the FDA in late 2020 or early 2021; the
potential for lumateperone to represent an advancement for the
treatment of bipolar depression; 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: we may encounter issues or
other challenges in commercializing CAPLYTA for the treatment of
schizophrenia, including but not limited to negative impacts from
the COVID-19 pandemic, ongoing pricing negotiations with certain
payors that have not finalized their assessments, and performance
of our sales activity, and that results achieved in CAPLYTA in the
treatment of schizophrenia 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;
there can be no guarantee that the sNDA for lumateperone for the
treatment of bipolar depression will be submitted within the target
timelines or that the sNDA will be approved by the FDA without a
request for the submission of additional information or at all; 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 Relations
646-440-9333
Burns McClellan, Inc. Lisa Burns
jgrimaldi@burnsmc.com212-213-0006
MEDIA INQUIRIES:
Ana Fullmer Corporate Media Relations W2Owcg
afullmer@wcgworld.com202-507-0130
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