NEW YORK, Dec. 18, 2018 (GLOBE NEWSWIRE) -- 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
