Intra-Cellular presents data from CAPLYTA adjunctive MDD Phase 3 program

Intra-Cellular (ITCI) Therapies announced presentations at the 63rd Annual Meeting of the American College of Neuropsychopharmacology, ACNP, which included new efficacy, safety, and tolerability analyses from its CAPLYTA adjunctive major depressive disorder, MDD, pivotal program. Poster T126 and W85: These poster presentations highlight the efficacy of lumateperone 42mg adjunctive to anti-depressant therapy shown in two similarly designed trials. In both studies, MADRS response and remission rates were significantly greater with lumateperone compared to placebo. Lumateperone plus ADT significantly improved self-reported anxiety symptoms, as measured by the GAD-7 total score, compared with placebo from baseline to Day 43. Poster W84: A pooled analysis of Studies 501 and 502 demonstrates the safety and tolerability of lumateperone 42 mg plus ADT in patients with MDD who had inadequate response to ADT. Poster W88: The poster reports on a post-hoc analysis from Study 403 evaluating the efficacy of lumateperone 42mg monotherapy in improving the anhedonia factor score in patients with MDD or bipolar depression with mixed features. The results from this analysis support lumateperone to treat the broad range of anhedonia symptoms of a major depressive episode in these patient populations.