Intra-Cellular Therapies Announces Completion of Phase I Single Rising Dose
Trial of First-in-Class Selective Phosphodiesterase 1 (PDE1) Inhibitor and
Reports Top-line Safety and Pharmacokinetic Findings
NEW YORK, Feb. 19, 2013
NEW YORK, Feb. 19, 2013 /PRNewswire/ --Intra-Cellular Therapies, Inc. ("ITI")
today announced the completion of a Phase I single rising dose study of its
phosphodiesterase 1 (PDE1) inhibitor, ITI-214. ITI-214, a novel,
first-in-class selective PDE1 inhibitor, was discovered by ITI and is in
development under an exclusive collaboration with Takeda Pharmaceutical
Company Limited for the treatment of Cognitive Impairment Associated with
The primary objectives of the Phase I study were to determine the safety,
tolerability and pharmacokinetic profile of single oral doses of ITI-214 in
healthy volunteers. The study was conducted as a randomized, double-blind,
placebo-controlled study in 70 subjects. The results indicated that ITI-214
was safe and well-tolerated across a broad range of single oral doses.
Moreover, ITI-214 demonstrates a favorable pharmacokinetic profile consistent
with once-a-day dosing. The study represents a significant milestone as it is
the first demonstration of the safety of a PDE1 inhibitor in a Phase 1
"We are pleased with the advancement of ITI-214 in clinical development,"
stated Sharon Mates, Ph.D., Chairman and Chief Executive Officer of
Intra-Cellular Therapies. "The data obtained for ITI-214 support its
continued development for the treatment of Cognitive Impairment Associated
with Schizophrenia and other neuropsychiatric and neurological disorders."
Schizophrenia is a major neuropsychiatric disorder that affects over one
percent of the world population with an illness that begins in late
adolescence and lasts a lifetime. Its best known symptoms are "positive
symptoms", which include hallucinations and delusions; but other mental
functions are also affected, including social and motivational skills
("negative symptoms") and cognitive behaviors, like inattention and poor
memory. Current antipsychotics are effective primarily on reducing positive
symptoms but are largely ineffective at reducing negative and cognitive
symptoms. The medical need in this disease area is enormous.
About PDE1 Inhibitors
These compounds are unique, orally available, investigational drugs being
developed for the treatment of cognitive impairments accompanying
schizophrenia and other neurological and neuropsychiatric disorders, including
Alzheimer's disease, Attention Deficit Hyperactivity Disorder and Parkinson's
disease. These compounds may also have the potential to improve motor
dysfunction associated with these disorders. These compounds are very
selective for the PDE1 subfamily relative to other PDE subfamilies. They have
no known significant off target activities at other enzymes, receptors or ion
About Intra-Cellular Therapies, Inc.
Intra-Cellular Therapies, Inc. (ITI) is a biopharmaceutical company that is
developing novel drugs for the treatment of diseases and disorders of the
Central Nervous System (CNS). The Company was formed in 2002 to exploit
intracellular signaling pathways of the brain in its efforts to develop novel
CNS therapeutics. The Company's initial efforts were built on the insights
generated from the Nobel Prize winning science of Dr. Paul Greengard at The
Rockefeller University, the scientific founder of ITI. Using novel
technologies developed at ITI, the Company has developed a pipeline of drugs
that have the potential to treat a wide range of diseases associated with the
CNS. Additional information about ITI is available through its corporate
Allen A. Fienberg, Ph.D., Vice President, Business Development, Intra-Cellular
Therapies, Inc., +1-212-923-3344; or Lisa Burns (Investors), or Justin Jackson
(Media), both of Burns McClellan, Inc., +1-212-213-0006, firstname.lastname@example.org.
SOURCE Intra-Cellular Therapies, Inc.
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