**Intra-Cellular Therapies Announces Positive Topline Results for MDD Treatment**
Intra-Cellular Therapies, Inc. (ITCI), a prominent biopharmaceutical company, revealed on Tuesday encouraging topline results from Study 502, which assessed the efficacy of lumateperone 42 mg as an adjunctive therapy to antidepressants for Major Depressive Disorder (MDD) treatment.
This trial, alongside the previously reported positive findings from Phase 3 Study 501, supports the foundation for the supplemental New Drug Application (sNDA) for lumateperone used in adjunctive treatment of MDD. The company plans to submit this sNDA to the U.S. Food and Drug Administration (FDA) in the latter half of 2024.
The primary endpoint in Study 502 was met by lumateperone 42 mg administered once daily alongside antidepressants, demonstrating a statistically significant and clinically meaningful reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to the placebo at the 6-week mark.
Additionally, lumateperone 42 mg met the key secondary endpoint by showing a statistically significant and clinically meaningful reduction in the Clinical Global Impressions-Severity (CGI-S) score compared to the placebo at Week 6.
Patients reported considerable improvement in depressive symptoms measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16) with lumateperone 42 mg. Importantly, the treatment was generally safe and well-tolerated throughout the study.
The study included 480 patients who were randomized in a 1:1 ratio to receive either lumateperone 42 mg plus an antidepressant or a placebo plus an antidepressant, aimed at evaluating the effectiveness and safety of lumateperone as an adjunctive treatment for patients with MDD. The initial MADRS total score stood at 30.8 for the lumateperone group and 31.5 for the placebo group.
These positive findings reaffirm Intra-Cellular Therapies' commitment to advancing more effective treatment options for those suffering from Major Depressive Disorder.
