Intra-Cellular Therapies Announces Update on ITI-007-201 Clinical Trial for Treatment of Agitation in Patients with Probable ...
December 18 2018 - 8:30AM
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical
company focused on the development of therapeutics for central
nervous system (CNS) disorders, today announced an independent data
monitoring committee (DMC) has completed a pre-specified interim
analysis of the Company’s ongoing clinical trial with low-dose
lumateperone (9 mg ITI-007) for the treatment of agitation in
patients with probable Alzheimer's disease (Study 201). The
DMC concluded that Study 201 is not likely to meet its primary
endpoint upon completion and therefore recommended the study should
be stopped for futility. As a result of this recommendation,
the Company has determined to discontinue Study 201.
Lumateperone was generally well tolerated in Study 201 and the
decision to discontinue the study was not related to
safety. The Company does not expect that these results will
impact any of its other ongoing development programs.
“We are disappointed for patients suffering from Alzheimer's
disease that the interim analysis did not detect a signal that
would warrant continuation of this study. Effective clinical study
design is a challenge, especially for a therapeutic indication for
which there are no approved treatments," said Dr. Sharon Mates,
Chairman and CEO of Intra-Cellular Therapies. “We intend to
analyze the full data set when it is available to determine the
next steps in our program for patients with probable Alzheimer’s
disease and agitation. On behalf of everyone at
Intra-Cellular Therapies, I would like to thank all of the
patients, caregivers, investigators and clinical research personnel
involved with this study.”
About Study 201
Study 201 was a Phase 3 multicenter, randomized, double-blind,
placebo-controlled clinical trial in patients with a clinical
diagnosis of probable Alzheimer's disease and clinically
significant symptoms of agitation. In this trial, patients were
randomized to receive 9 mg ITI-007 or placebo in a 1:1 ratio orally
once daily for four weeks. The primary efficacy measure utilized
the Cohen-Mansfield Agitation Inventory — Community version
(CMAI-C). Other efficacy measures included a Clinical Global
Impression scale for Severity (CGI-S) of illness. Safety and
tolerability were also assessed in the trial.
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 is under review by the FDA for the treatment of
schizophrenia and is in Phase 3 clinical development for the
treatment of bipolar depression. 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 and for the treatment of heart
failure.
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 clinical and non-clinical
development plans; the progress, timing and results of our clinical
trials; the safety and efficacy of our product development
candidates; our beliefs about the potential uses and benefits of
lumateperone; our expectation that the results of this interim
analysis and the decision to discontinue Study 201 will not impact
any of our other ongoing development programs; 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:
whether the NDA for lumateperone for the treatment of schizophrenia
will be accepted and approved by the FDA; risks associated
with our current and planned clinical trials; we may encounter
unexpected safety or tolerability issues with lumateperone 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.
Contact:
Intra-Cellular Therapies, Inc. Juan Sanchez, M.D. Vice
President, Corporate Communications and Investor Relations
646-440-9333
Burns McClellan, Inc. Lisa Burns agray@burnsmc.com
212-213-0006
MEDIA INQUIRIES:
Patrick Ryan, Esq. Corporate Media Relations, W2Owcg
pryan@wcgworld.com
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