Intra-Cellular to present at 2024 Psych Congress, NEI Congress

Intra-Cellular (ITCI) Therapies announced presentations about lumateperone including the results from Phase 3 adjunctive Major Depressive Disorder Studies 501 and 502 at Psych Congress held October 29- November 2 in Boston and Neuroscience Education Institute Congress being held November 7-10 in Colorado Springs. Studies 501 and 502 demonstrated robust efficacy of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD. In the primary endpoint, the Montgomery-Asberg Depression Rating Scale total score, lumateperone demonstrated a large separation versus placebo of 4.9 points in Study 501 and 4.5 points in Study 502 with robust effect sizes of 0.61 and 0.56 respectively. This efficacy was confirmed in both studies not only by the primary endpoint, the MADRS total score, but also by the strong results in the clinician rated Clinical Global Impression Scale for Severity of Illness scale and the patient reported Quick Inventory of Depressive Symptomatology Self-Report scale. CAPLYTA’s efficacy results were complemented with a favorable metabolic, weight and movement disorder profile. In the adjunctive MDD setting these data present a compelling clinical profile for lumateperone in the treatment of MDD. These results further support the Company’s vision for CAPLYTA to become a leading option for patients and providers across mood disorders.