Intra-Cellular Therapies, Inc. announced top-line results from two Phase III trials (Study 401 and Study 404) evaluating lumateperone as monotherapy in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.  
 
In Study 404, lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score.  Study 404 also met its key secondary endpoint, Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S).  In both trials, lumateperone demonstrated a favorable safety profile and was generally well-tolerated.
 
These results were supported by statistically significant benefits on responder rates and remission rates. In addition, in subgroup analyses of patients with Bipolar I and patients with Bipolar II disorder lumateperone 42 mg demonstrated statistically significant improvement versus placebo on the MADRS total score in both subgroups.
 
“We consider today’s positive results to be a significant milestone in our bipolar depression program. The distinct pharmacological profile of lumateperone and positive clinical results in schizophrenia and bipolar depression further support the potential for benefits in a broad range of neuropsychiatric conditions, including major depressive disorder,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.  “It is an exciting time at ITCI as we prepare for the launch of lumateperone for the treatment of schizophrenia, pending FDA approval.”