Intra-Cellular Therapies Presents Results from ITI-214 Phase 1/2 Clinical Trial in Patients with Parkinson’s Disease at 2018 American Neurological Association Annual Meeting
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.
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.
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
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Source: Intra-Cellular Therapies Inc.