Intra-Cellular Therapies Announces Commencement of Enrollment of a Clinical Trial Evaluating ITI-214 in Patients with Parkinson’s Disease

New York, New York, UNITED STATES

NEW YORK, Oct. 03, 2017 (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 the Company has commenced enrollment in the ITI-214-105 Phase 1/2 clinical trial in patients with Parkinson’s disease (PD).

“ITI-214 is a potent and selective phosphodiesterase 1 (PDE1) inhibitor. Following the favorable safety and tolerability results in our Phase 1 program, we are pleased to announce the advancement of ITI-214 for the treatment of patients with Parkinson’s disease,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “This study is designed to evaluate the safety and tolerability of ITI-214 in this patient population, as well as evaluate the ability of ITI-214 to treat both motor and nonmotor symptoms associated with Parkinson’s disease and to provide a framework for future trials to assess disease modification.”

About the ITI-214-105 Phase 1/2 Clinical Trial

This is a Phase 1/2 randomized, double-blind, placebo-controlled, multiple rising dose study of ITI-214 in patients with idiopathic PD. Patients with mild to moderate PD who are maintained on stable PD therapy will be randomly assigned to placebo or ITI-214 1, 3 or 10 mg administered orally once daily for 7 days. The primary objective is to evaluate the safety and tolerability of ITI-214 in this patient population. Secondary objectives are to evaluate the pharmacokinetic profile of ITI-214 and explore its potential utility to control motor fluctuations and to evaluate treatment of non-motor symptoms (daytime sleepiness, dysautnomia) associated with PD. Biomarkers of disease progression (inflammation) will be assessed.

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 as well as patients with schizophrenia. 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 for motor symptom control at lower doses of dopamine replacement therapies while inhibiting the adverse dyskinesias induced by 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.  In preclinical studies, 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 Parkinson’s Disease

Over 1.0 million and 1.2 million patients in the United States and Europe, respectively, live with Parkinson’s disease. PD is a progressive neurodegenerative disorder largely affecting dopamine systems in the brain and characterized by motor impairment and nonmotor symptoms, including but not limited to excessive daytime sleepiness, cognitive impairment, mood disorders and dysautonomia. Dopamine replacement therapies, with L-DOPA, address early motor symptoms, but are insufficient as the disease progresses and have limiting side effects. There remains a large unmet need for effective treatments to sustain the utility of dopaminergic therapies and to address nonmotor symptoms.

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.


Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations

Burns McClellan, Inc.
Lisa Burns
Justin Jackson (Media)