Intra-Cellular Therapies Inc. said it will discontinue a late-stage study of lumateperone, or ITI-007, to treat agitation in patients with probable Alzheimer's disease.
The decision is based on a recommendation from the trial's independent data monitoring committee, which, based on an interim analysis of the study, said the medicine is unlikely to meet its endpoint.
The double-blind randomized trial called Study 201 enrolled about 360 participants over the age of 55 and compared the efficacy of a 9-milligram dose of lumateperone against placebo in treating agitation.
Intra-Cellular noted the decision to discontinue the study does not impact any of its other ongoing development programs.
The U.S. Food and Drug Administration granted fast-track designation to lumateperone to treat schizophrenia and is reviewing the drug's application in that indication with a target action date set for Sept. 27, 2019.
New York-based Intra-Cellular Therapies is also developing lumateperone to treat bipolar disorder, depression, and other neuropsychiatric and neurological disorders.