Intra-Cellular stops Phase II of lumateperone for agitation in dementia for futility

Intra-Cellular Therapies Inc. (NASDAQ:ITCI) discontinued the Phase III Study 201 of low-dose lumateperone (ITI-007) to treat agitation in patients with dementia, including Alzheimer's disease, after a prespecified interim analysis by an IDMC showed that the product was unlikely to meet the primary endpoint vs. placebo. The company said it will analyze the full data set when it is available to determine next steps for lumateperone in the indication.

The double-blind, U.S. trial was slated to enroll about 360 patients to receive placebo or once-daily 9 mg oral lumateperone and evaluated a primary endpoint of the change from baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) score at week four...