Biopharmaceutical company Intra-Cellular Therapies, Inc. (ITCI) announced Tuesday positive topline results from Study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of Major Depressive Disorder (MDD).
This trial, in conjunction with the previously reported positive Phase 3 study, Study 501, forms the basis for lumateperone sNDA for the adjunctive treatment of MDD. The company expects to submit this sNDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024.
Lumateperone 42 mg given once daily as adjunctive therapy to antidepressants met the primary endpoint in Study 502 by demonstrating a statistically significant and clinically meaningful reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo at Week 6.
Lumateperone 42 mg also met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the CGI-S score compared to placebo at Week 6.
In this study, lumateperone 42 mg robustly improved depressive symptoms as reported by patients as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16). Lumateperone was also generally safe and well-tolerated in this study.
In this study, 480 patients were randomized (1:1) to lumateperone 42 mg plus antidepressant or placebo plus antidepressant to evaluate the efficacy and safety of lumateperone as an adjunctive treatment to antidepressants in patients with MDD. The baseline MADRS total score was 30.8 for lumateperone 42 mg and 31.5 for placebo.