Intra-Cellular announces presentations at 2024 ECNP Congress

Intra-Cellular Therapies announced presentations of lumateperone including the results from Phase 3 adjunctive Major Depressive Disorder, Study 501 at the 37th European College of Neuropsychopharmacology Congress being held September 21 – 24, 2024 in Milan, Italy. Details of the presentations are as follows: Study 501 Presentations: Oral presentation: “Adjunctive Lumateperone Significantly Improves Symptoms of Major Depressive Disorder: Topline Results From a Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial.” Monday, September 23, 15:00 – 16:20 CEST. P2127: “Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder: Results From a Randomised, Double-blind, Phase 3 Trial.” Monday, September 23 12:35 – 14:00 CEST. Study 403 Presentations: P2113: “Lumateperone in the Treatment of Patients With Major Depressive Disorder and Bipolar Disorder With Anxious Distress and Mixed Features.” Monday, September 23 12:35 – 14:00 CEST. P2096: “Lumateperone in the Treatment of Major Depressive Disorder and Bipolar Depression With Mixed Features: Efficacy Across Symptoms.” Monday, September 23 12:35 – 14:00 CEST. In Study 501, lumateperone met the primary endpoint of change from baseline at Week 6 on the Montgomery Asberg Depression Rating Scale total score versus placebo with a 4.9-point reduction. Statistically significant reductions in depressive symptoms as measured by the MADRS were seen at the earliest time point tested, Week 1, and these improvements continued throughout the course of the trial. Lumateperone also met the key secondary endpoint of change from baseline on the clinician-rated Clinical Global Impression Scale for Severity of Illness. On a patient-reported measure, the Quick Inventory of Depressive Symptomatology Self Report scale, patients reported robust reduction in their depressive symptoms. Adverse events were similar to those seen in prior studies of lumateperone as a treatment for bipolar depression and schizophrenia. Mean changes in key metabolic parameters including glucose, insulin, triglycerides, and total, LDL and HDL cholesterol were similar between lumateperone and placebo. Importantly, mean changes in weight were also similar to placebo. In an additional, similarly-designed trial, Study 502, lumateperone 42 mg plus an antidepressant met primary and key secondary efficacy endpoints and was generally safe and well tolerated in patients with MDD with inadequate antidepressant response. Details of Study 502 will be presented at upcoming conferences. Study 403 presentations highlight important analyses of lumateperone’s double-blind placebo-controlled study in patients with either MDD or bipolar depression exhibiting mixed features. Poster #2113 presents a post-hoc analysis of Study 403 evaluating lumateperone’s efficacy in the prespecified patient population with MDD or bipolar depression with mixed features who also met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria for anxious distress. In this analysis, lumateperone significantly improved depression symptoms and severity compared with placebo. Lumateperone also significantly improved MADRS inner tension single-item score in patients with co-morbid anxious distress. Both anxious distress and mixed features are specified in the DSM-5 and are common in patients with major depressive episodes associated with MDD and bipolar disorder. Patients with these specifiers have more severe symptoms, more comorbidities, increased suicide risk, and/or poorer treatment response than patients without these specifiers. Poster #2096 presents a post-hoc analysis of Study 403 individual MADRS items. Treatment with lumateperone significantly improved a broad range of depression symptoms across individual MADRS items.