Intra-Cellular (ITCI) Up as Second Depression Study Meets Goals

Core Insights - Intra-Cellular Therapies (ITCI) announced positive top-line results from Study 502, the second late-stage study evaluating lumateperone 42 mg for major depressive disorder (MDD) [1] - The study achieved statistically significant and clinically meaningful results in both primary and key secondary endpoints, indicating the drug's effectiveness [4][11] Study Results - Study 502 demonstrated a statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo at week six [11] - The key secondary endpoint showed a significant reduction in the Clinical Global Impression Scale score at week six [2] - Improvement in depressive symptoms was also noted through the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16) [3] Safety Profile - Lumateperone was generally safe and well-tolerated, with most adverse events being mild to moderate in severity [6] - Safety data from Study 502 aligns with previous studies of lumateperone for MDD, bipolar depression, and schizophrenia [6] Regulatory and Market Implications - The success of Studies 501 and 502 supports a regulatory filing for label expansion of lumateperone as an adjunctive treatment for MDD, anticipated in the second half of 2024 [14] - If approved, the eligible patient population for Caplyta will expand, potentially boosting revenues for the company [22] Market Performance - Following the announcement of positive results, ITCI's stock climbed 9.6% on June 18, with a year-to-date gain of 5.4% compared to the industry's 7.1% decline [15]