Intra-Cellular Therapies announced four data presentations at the American College of Neuropsychopharmacology 61st Annual Meeting highlighting the therapeutic use of CAPLYTA for the treatment of bipolar I and II depression. Monday December 5: Poster M78: "Metabolic Profile of Lumateperone in Late-Phase Clinical Trials for the Treatment of Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder": This poster presents a comprehensive weight and metabolic analysis of more than 1,200 patients that participated in our lumateperone late-stage bipolar depression program: two 6-week monotherapy and one 6-week adjunctive therapy placebo-controlled studies and a 6-month open label extension safety study. The results demonstrate that in patients with bipolar I or bipolar II disorder experiencing a major depressive episode, lumateperone 42-mg monotherapy or adjunctive therapy had a favorable cardiometabolic profile for both acute and long-term treatment. The results confirm the favorable effects of lumateperone 42mg on body weight and morphology as demonstrated by minimal and similar to placebo mean changes from baseline in weight, BMI and waist circumference in short-term studies and no increases seen in these parameters in the long-term OLE study. In addition, potentially clinically significant weight changes were assessed. In the short-term studies, no patients treated with lumateperone had PCS weight gain during treatment and, in the long-term OLE study, PCS weight loss was more common than PCS weight gain. Consistent with prior analyses, mean changes in key cardiometabolic parameters including fasting glucose, insulin, total cholesterol and triglycerides, were all similar to placebo. There were no clinically significant changes in these parameters in the long-term OLE study. Poster V19: "Efficacy of Lumateperone in Pooled Short-Term Late-Phase Clinical Trials for the Treatment of Major Depressive Episodes Associated With Bipolar II Disorder": This poster describes a pooled analysis of the efficacy of lumateperone 42 mg monotherapy and adjunctive therapy across three short-term, placebo-controlled Phase 3 studies in a subgroup of patients with depressive episodes associated with bipolar II disorder. The results demonstrate that in patients with bipolar II disorder experiencing a MDE, lumateperone 42-mg monotherapy or adjunctive therapy significantly improved symptoms of depression and disease severity compared with placebo. In patients with bipolar II disorder, lumateperone 42 mg significantly improved the Montgomery-Asberg Depression Rating Scale total score from baseline to week 6 compared with placebo. A higher proportion of bipolar II patients on lumateperone had a treatment response compared with placebo. Lumateperone significantly improved illness severity at week 6 as measured by the clinical global impression scales of severity. Further, there was significant improvement on the Quality-of-Life Enjoyment and Satisfaction Questionnaire – Short Form as compared to placebo. Poster V21: "Evaluation of Mania and Hypomania in Late-Phase Clinical Trials of Lumateperone in the Treatment of Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder": When treating patients with bipolar depression, switching to mania/hypomania represent important treatment-emergent adverse events to monitor. This poster presents analyses of measures of mania and hypomania across our short-term, placebo-controlled studies and long-term OLE study of lumateperone in patients with a MDE associated with bipolar I or bipolar II disorder. The poster highlights that the incidence of mania/hypomania events were similar between lumateperone 42 mg and placebo. Across short-term trials, the incidence of mania/hypomania TEAEs were rare, and if occurred, were mild or moderate in severity and similar between lumateperone and placebo. These TEAEs were also rare and mild or moderate in severity in the long-term OLE study. There were no notable changes from baseline in mean Young Mania Rating Scale. Total score in short-term, placebo-controlled studies and the long-term OLE study. Mean changes in CGI-BP-S Mania subscore were similar between lumateperone and placebo in short term trials and remained clinically stable throughout the long-term OLE study. Poster W79: "Lumateperone in the Treatment of Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: Evaluation of Extrapyramidal and Motor Symptoms in Late-Phase Clinical Trials": Lumateperone is a simultaneous modulator of serotonin, dopamine, and glutamate neurotransmission with low D2 receptor occupancy at the recommended dose of 42mg. Elevated levels of dopamine D2 occupancy are known to be associated with increases in extrapyramidal symptoms. This poster describes the incidence of EPS across our short-term, placebo-controlled studies and long-term OLE study of lumateperone in patients with a MDE associated with bipolar I or bipolar II disorder. The incidence of EPS-related TEAEs was low and mild or moderate in severity across short-term trials and the long-term OLE study. The use of concomitant benztropine and propranolol was rare. There were no notable changes from baseline in clinician-rated motor scale scores. The incidence of treatment-emergent parkinsonism and akathisia in the short-term, placebo-controlled studies was similar to placebo and was minimal in the OLE. In patients with bipolar I or bipolar II disorder experiencing a MDE, lumateperone 42-mg had a favorable EPS profile in both acute and long long-term treatment.
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