Intra-Cellular Therapies Announces Positive Phase 3 Topline Results from Study 501 Evaluating Lumateperone as Adjunctive Therapy in Patients with Major Depressive Disorder

Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints

Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.9 point reduction v. placebo; p<0.0001; Cohen’s d effect size (ES)= 0.61)

Lumateperone 42 mg also met the key secondary endpoint of change from baseline at Week 6 on the Clinical Global Impression Scale for Severity of Illness (CGI-S) (p<0.0001; ES= 0.67)

Statistically significant efficacy was seen at the earliest time point tested (Week 1) and maintained throughout the study in both the primary and the key secondary endpoints

Statistically significant efficacy was also seen in the Quick Inventory of Depressive Symptomatology Self- Report (QIDS-SR) scale, a patient self-reported measure of symptom severity of depression (p<0.0001)

Favorable safety and tolerability profile generally consistent with prior lumateperone trials

Conference call scheduled today at 8:30 a.m. ET

NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced positive topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). 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.”