Lumateperone fails to meet endpoint in Study 201 to treat agitation in Alzheimer's patients.-Intra-Cellular Therapies

Intra-Cellular Therapies, Inc. 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.

About Study 201: Study 201 was a Phase III 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.