Phase 3 data supports lumateperone for bipolar depression

Intra-Cellular Therapies, Inc. announced positive results from a phase 3 clinical trial evaluating lumateperone as monotherapy in the treatment of major depressive episodes associated with bipolar I or bipolar II disorder, according to a press release.

In Study 404, lumateperone improved depressive symptoms compared with placebo as measured by change in MADRS total score (least squares mean difference = 4.6 points; P < .001) as well as improved symptom severity as measured by change in Clinical Global Impression Scale for Bipolar for Severity of Illness total score (P < .001).

In another trial (Study 401), lumateperone did not met the primary endpoint of statistical separation from placebo; however, lumateperone 42 mg and 28 mg reduced depressive symptoms by 20.7 and 18.9 points on the MADRS total score compared with 19.7 points on placebo.

Lumateperone had a favorable safety profile and was generally well-tolerated in both trials, according to the release.

“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,” Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, said in the release. “It is an exciting time at ITCI as we prepare for the launch of lumateperone for the treatment of schizophreniav, pending FDA approval.”