Intra-Cellular Therapies to Host a Conference Call Today
at 8:30 a.m. ET
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical
company focused on the development of therapeutics for central
nervous system (CNS) disorders, today announced positive topline
data from the first part of an open-label safety switching study in
which 302 patients with stable symptoms of schizophrenia were
switched from standard-of-care antipsychotic medications to
lumateperone (ITI-007 60 mg) with no dose titration of lumateperone
required for a 6-week treatment duration, then switched back to
standard-of-care. Many currently available antipsychotic agents are
associated with motor side effects and/or weight gain,
cardiovascular liabilities, dyslipidemia, and hyperglycemia. In
this study, lumateperone was generally well tolerated with a
favorable safety profile. Statistically significant improvements
from standard-of-care baseline were observed in body weight,
cardiometabolic and endocrine parameters in patients with stable
symptoms of schizophrenia when switched to lumateperone and
worsened again when switched back to standard-of-care medication.
Additionally, treatment with lumateperone was not associated with
the motor or cardiovascular disturbances often associated with
other antipsychotic medications. These data are consistent with
previous study results reflecting a safety profile similar to
placebo in placebo-controlled trials with lumateperone in patients
with acutely exacerbated schizophrenia and extend this favorable
safety profile to this stable patient population. Symptoms of
schizophrenia did not worsen upon switch to lumateperone from
standard-of-care. Rather, statistically significant improvement
from baseline was observed in the Positive and Negative Syndrome
Scale (PANSS) mean total score. Notably, greater improvements were
observed in subgroups of patients with elevated symptomatology such
as those with comorbid symptoms of depression and those with
prominent negative symptoms.
“Significant weight-gain or other cardiometabolic side effects
or motor disturbances may prompt treating physicians to switch
antipsychotics as a treatment management strategy,” said Dr.
Christoph Correll, MD, Professor of Psychiatry and Molecular
Medicine, Hofstra Northwell School of Medicine. “This open-label
safety switching study showing improvements in important
cardiometabolic and motor parameters, was conducted in an
outpatient setting representative of common clinical practice.
Results confirm in a more generalizable population the safety
profile of lumateperone that demonstrated a lack of metabolic,
motor and cardiovascular issues in prior large placebo-controlled
trials. These new findings are very encouraging as improving
psychiatric symptoms without compromising physical health in people
with schizophrenia is a very important goal.”
“In addition to the favorable safety profile seen in this study,
we are encouraged by the efficacy profile of lumateperone in
patients with stable symptoms of schizophrenia switched from
standard-of-care antipsychotic medication," said Dr. Sharon Mates,
Chairman and CEO of ITCI. “The observations of statistically
significant symptomatic improvements upon switch from
standard-of-care in patients taking lumateperone warrant further
investigation, especially in those patients with comorbid symptoms
of depression or with prominent negative symptoms who are
particularly underserved by currently available treatments.”
About the Lumateperone Open-label Safety Switching
Study
To assess long-term safety and to observe the impact of
switching from standard-of-care antipsychotic medications, the
Company is conducting an open-label safety switching study in
stable patients with schizophrenia switched to lumateperone
(ITI-007 60 mg) from standard-of-care antipsychotic therapy. This
study is being conducted in the United States in two parts. The
first part has completed clinical conduct and included a 6-week
treatment duration with lumateperone followed by a 2-week period
where patients are switched back to standard-of-care. This study
assesses both the impact of switching to lumateperone from
standard-of-care antipsychotics as well as the impact of switching
back to standard-of-care antipsychotics from lumateperone. The
second part of the study, the Company’s long-term safety study in
schizophrenia, is enrolling patients for up to 1-year treatment
duration with lumateperone following switch from standard-of-care.
Clinical conduct of the second part of the long-term safety study
of lumateperone is ongoing.
In this first part of the open-label safety
switching study, 302 patients with schizophrenia were enrolled and
treated for 6 weeks with lumateperone (ITI-007 60 mg) administered
orally once daily in the evening. Of the 302 patients enrolled, 218
(72.2%) completed the treatment period. To be eligible for
inclusion in the study, patients must have had a clinical diagnosis
of schizophrenia according to the Diagnostic and Statistical Manual
of Mental Disorders (DSM-5) and be stable with respect to their
schizophrenia symptoms. The primary objective was to determine the
safety of lumateperone. Safety is measured by treatment-related
adverse events, vital signs, electrocardiograms, clinical
laboratory values, physical and neurological exams and standardized
clinical assessments such as the Simpson Angus Scale (SAS), the
Barnes Akathisia Rating Scale (BARS), the Abnormal Involuntary
Movement Scale (AIMS), and the Columbia – Suicide Severity Rating
Scale (C-SSRS). Secondary objectives were to determine the
effectiveness of lumateperone as measured by change from baseline
to improve psychopathology on the Positive and Negative Syndrome
Scale (PANSS), improve social functioning as measured by the PANSS
Pro-Social Factor and the Personal and Social Performance Scale
(PSP), and reduce depression as measured by the Calgary Depression
Scale for Schizophrenia (CDSS). Analyses in pre-specified subgroups
were performed.
No dose titration was needed for the administration
of lumateperone when patients were switched from standard-of-care
antipsychotics to lumateperone. Patients could be started on an
active dose of ITI-007 60 mg from Day 1. Consistent with good
clinical care, patients were tapered down from their previous
antipsychotic medication during the screening period or switched to
lumateperone from one day to the next if no tapering down of the
previous antipsychotic medication was clinically indicated. In this
study, the most recent antipsychotic taken prior to screening, in
descending order of frequency, included risperidone, quetiapine,
aripiprazole, olanzapine, lurasidone, ziprasidone, haloperidol,
paliperidone, perphenazine, asenapine, brexpiprazole and
iloperidone.
The most frequent drug-related adverse event was
somnolence occurring in 6.6% of patients receiving ITI-007 60 mg
dosed daily in the evening. The proportion of patients reporting
somnolence in this study was lower than that observed with morning
dosing in previous lumateperone controlled trials and similar to
that seen with placebo in those studies. There were no drug related
serious adverse events. The proportion of patients experiencing
motor side effects on lumateperone was low: akathisia (0.3%), and
extrapyramidal side effects (0.7%). There were no signs of emerging
extrapyramidal side effects, akathisia or dyskinesia as measured by
the SAS, BARS or AIMS, respectively.
In contrast to many other antipsychotics that cause
weight gain, in this study mean body weight, body mass index, and
waist circumference change from baseline statistically
significantly decreased over 6 weeks of treatment with lumateperone
(p = 0.001, p = 0.001, p=0.005, respectively). Lumateperone also
demonstrated a favorable cardiometabolic and endocrine safety
profile. Prespecified comparisons of mean change from baseline to
Day 42 on lumateperone revealed statistically significant
reductions in total cholesterol (p = 0.002), LDL cholesterol (p =
0.001), triglycerides (p = 0.035) and prolactin (p = 0.001). These
key laboratory mean values worsened again when patients who
completed treatment with lumateperone returned to standard-of-care,
with prolactin (p<0.001) and triglycerides (p=0.01) reaching
statistically significant worsening after only 2 weeks on
standard-of-care. There was a trend for improvement in
insulin sensitivity with time on lumateperone (glucose levels were
unchanged while insulin levels decreased, p = 0.055). This trend
reversed when subjects were switched back from lumateperone to
standard-of-care. The cardiovascular safety of lumateperone was
also favorable with no change in multi-positional blood pressure or
heart rate, no orthostasis, and no QTc interval prolongation.
The mean PANSS total score, at baseline 62.7, was
consistent with a stable schizophrenia population and nonetheless
symptoms of schizophrenia generally improved with lumateperone
treatment or remained stable upon switch from standard-of-care
antipsychotic therapy. Statistically significant improvements were
observed in change from baseline of the PANSS total scores in this
stable patient population switched from standard-of-care
antipsychotic therapy (p = 0.003). Mean Clinical Global Impression
Scale for Severity of Illness (CGI-S) scores improved in those
patients who completed 6 weeks of lumateperone treatment (p =
0.003). In this safety study, it is important that patients
receiving open-label lumateperone did not worsen when switched from
standard-of-care antipsychotic medication. Improvements with
lumateperone were seen even in these presumed symptomatically
stable patients as demonstrated by a responder analysis for the
PANSS total score which indicated greater than 20% of patients
improved by at least 20%, a widely accepted standard of clinical
meaningfulness in the medical community.
Statistically significant improvements were also
seen in the positive symptom subscale scores (p < 0.001),
general psychopathology subscale scores (p = 0.014), and
PANSS-derived Prosocial Factor scores (p < 0.001) as well as in
social functioning as measured by the PSP scale in this stable
patient population (p < 0.001). Negative symptoms also improved
significantly with lumateperone treatment in a subgroup of patients
(N = 36) with prominent negative symptoms at baseline as measured
by the negative symptom subscale (p = 0.029) and the Marder
Negative Factor (p = 0.014). In a subgroup of patients with
comorbid symptoms of depression (N=17), as measured by a CDSS score
of greater than 6, symptoms of depression improved significantly (p
= 0.001).
While efficacy data in an open label study should
be interpreted cautiously due to the absence of a parallel control
group, the Company is encouraged by the efficacy findings
associated with switching to lumateperone in this study population
and believes they warrant further investigation. Further data from
this study will be presented at upcoming medical conferences.
In two large placebo-controlled trials in patients with acute
schizophrenia, lumateperone has demonstrated a statistically
significant reduction of symptoms of psychosis as measured by
change from baseline on the PANSS total score compared to placebo
with supportive evidence from a third study. In all of these
studies lumateperone has been well-tolerated, with a safety profile
similar to placebo, and with clinically relevant and statistically
significant safety and tolerability advantages when directly
compared in two studies with risperidone used as an active control,
the most commonly prescribed antipsychotic for the treatment of
schizophrenia. These findings include no significant adverse
effects on cardiovascular parameters, weight, blood lipids,
glucose, prolactin and motor function. The data from the present
open label safety study of patients with stable symptoms of
schizophrenia switched from standard-of-care antipsychotic therapy
are consistent with and extend previous data with over 1,500 people
exposed to date.
Conference Call and Webcast Details
Intra-Cellular Therapies will host a live conference call and
webcast today at 8:30 a.m. ET, during which management will discuss
the corporate update on the schizophrenia program. 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 81934888. Please dial in
approximately 10 minutes prior to the call.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the
treatment of neuropsychiatric and neurodegenerative diseases and
diseases of the elderly, including Parkinson’s and Alzheimer’s
disease. The Company is developing its lead drug candidate,
lumateperone (also known as ITI-007), for the treatment of
schizophrenia, bipolar disorder, behavioral disturbances in
patients with dementia, including Alzheimer’s disease, depression
and other neuropsychiatric and neurological disorders.
Lumateperone, a first-in-class molecule, is in Phase 3 clinical
development for the treatment of schizophrenia, bipolar depression
and agitation associated with dementia, including Alzheimer’s
disease. The Company is also utilizing its phosphodiesterase (PDE)
platform and other proprietary chemistry platforms to develop drugs
for the treatment of CNS and other disorders. The lead molecule in
the Company’s PDE1 portfolio, ITI-214, is in development for the
treatment of symptoms associated with Parkinson's
disease.
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 view that the positive efficacy
observations in this open label study warrant further
investigation; factors that may prompt treating physicians to
switch antipsychotics as a treatment management strategy; the
effect of lumateperone’s safety profile on medication adherence and
patient outcomes; further clinical conduct in this switching study;
future presentations of data at upcoming medical conferences; our
belief that lumateperone, if approved, will be an attractive
treatment option for schizophrenia; 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: this switching study was an
open label study and its efficacy observations may not be
replicated in any future controlled trials; any toxicities
discovered in our long-term safety study of lumateperone in
patients with schizophrenia and nonclinical studies could delay or
prevent our filing of an NDA; the FDA may place our long-term
safety study on a clinical hold, which would delay or prevent us
from completing the safety study and from filing an NDA; our
current and planned clinical trials, other studies for
lumateperone, and 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.
Contact:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333
Burns McClellan, Inc.
Lisa Burns
Justin Jackson (Media)
jjackson@burnsmc.com
212-213-0006
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