NEW YORK, NY, USA I December 18, 2018 I 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.

SOURCE: Intra-Cellular Therapies