Intra-Cellular announces Phase 3 results from Study 501

Intra-Cellular Therapies announced positive topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder. Topline results from our second Phase 3 study, Study 502, are anticipated late in the second quarter of this year. “The positive Phase 3 results in MDD represent a significant step towards our goal of further establishing CAPLYTA as a first-choice treatment across mood disorders,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make CAPLYTA a compelling option as an adjunctive treatment for MDD, if approved. At ITCI, we are committed to bringing improved treatment options to patients with major neuropsychiatric conditions through our efforts to expand CAPLYTA’s label and advance our pipeline.” Lumateperone 42 mg given once daily as adjunctive therapy to antidepressants met the primary endpoint in Study 501 by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6. In the modified intent-to-treat study population, the least squares mean reduction from baseline for lumateperone 42 mg was 14.7 points, versus 9.8 points for placebo. 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. Statistically significant efficacy was seen at the earliest time point tested and maintained throughout the study in both the primary and the key secondary endpoints.