NEW YORK, Oct. 17, 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 it will present top line
results from the Company’s Phase 1/2 clinical study of ITI-214, its potent and selective phosphodiesterase 1 (PDE1) inhibitor, in
patients with mild to moderate Parkinson’s disease (PD) being maintained on stable (concomitant) PD medication, at the 2018
American Neurological Association Annual Meeting being held in Atlanta, Georgia, October 21-24, 2018. This multiple ascending dose
cohort study was designed to evaluate the safety and tolerability of ITI-214 and to explore the potential for ITI-214 to treat both
motor and nonmotor symptoms associated with PD.
The poster presentation (M217) entitled, “A Phase I/II Clinical Study of ITI-214, a Novel Phosphodiesterase I Inhibitor, for the
Treatment of Motor and Non-motor Symptoms of Parkinson’s Disease” is being presented Monday, October 22, 2018, 5:30 pm
- 7:00 pm ET.
About ITI-214
ITI-214 is a potent and selective phosphodiesterase 1 (PDE1) inhibitor. As the clinical lead compound in the Company’s PDE1
portfolio, ITI-214, has been found to be generally well tolerated with a favorable safety profile in four Phase 1 clinical trials,
in healthy volunteers. Inhibitors of PDE1 block the breakdown of cyclic nucleotides (cAMP, cGMP), potentiating downstream
intracellular signaling. The PDE1 enzyme is highly active in pathological or disease states, and our PDE1 inhibitors are designed
to reestablish normal function in these disease states. PDE1 inhibitors have minimal effect on normal function, only acting when
cells in the nervous system are stimulated. These "on-demand" effects make this an exciting and novel approach for the treatment of
disease. In animal models, inhibition of PDE1 has been shown to reduce neuroinflammation and to reduce neurodegeneration. The
mechanism of action of PDE1 inhibitors suggests therapeutic potential across a variety of neurological and cardiovascular
diseases.
Preclinical studies suggest that PDE1 inhibitors potentiate L-DOPA and other dopamine replacement therapies yielding improved
motor symptom control while reducing adverse motor complications associated with these treatments. Preclinical models have also
shown the potential for PDE-1 inhibitors to address non-motor symptoms such as excessive daytime sleepiness, cognitive impairment
and other non-motor symptoms. The Company has recently demonstrated the importance of ITI-214 and inhibition of PDE1 in
reducing neuroinflammation and in regulating microglial function suggesting utility in treating neurodegenerative and
neuropsychiatric disease.
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. Ultimately, treatments are needed that protect dopamine containing neurons from damage, providing novel approaches
for slowing or halting disease progression. The impact of ITI-214 may be examined in future, longer term studies.
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 nonclinical development plans for our PDE compounds, including our expectations
concerning the timing of trials and studies and the availability of data; our beliefs about the potential uses and benefits of
ITI-214; 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: our 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:
INVESTORS:
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, WCG World
pryan@wcgworld.com
