Positive phase III topline results from Study 501 evaluating lumateperone as adjunctive therapy in patients with major depressive disorder

Topline results from our second Phase III study, Study 502, are anticipated late in the second quarter of this year.

“The positive Phase III 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 (mITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 14.7 points, versus 9.8 points for placebo (LS mean difference = -4.9 points; p<0.0001; es="0.61)." 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 (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.

In this study , lumateperone 42 mg robustly improved depressive symptoms as reported by patients as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16) (p<0.0001). the qids-sr-16 is a 16-item patient-rated scale of symptom severity in depression. it assesses nine key symptoms of depression: insomnia hypersomnia, low mood, appetite weight changes, impaired self-perception, concentration difficulties, loss of interest pleasure, suicidal ideation, psychomotor agitation and fatigue. in this study, 485 patients were randomized (1:1) to lumateperone 42 mg plus antidepressant or placebo plus antidepressant to evaluate the efficacy and safety of lumateperone as an adjunctive treatment to antidepressants in patients with mdd. the baseline madrs total score was 30.4 for lumateperone 42 mg and 30.0 for placebo.>

Lumateperone was generally safe and well-tolerated in this study. The most commonly reported adverse events that were observed at a rate greater than or equal to 5% and at least twice the rate of placebo in the total population were dry mouth (10.8%), fatigue (9.5%) and tremor (5.0%). Adverse events were mostly mild to moderate and resolved within a short period of time. These adverse events were similar to those seen in prior studies of lumateperone as a treatment for bipolar depression and schizophrenia.

“MDD is a highly prevalent condition and there is a need for efficacious treatments with favorable safety and tolerability profiles given the majority of patients do not benefit from their initial therapy or suffer from side effects associated with existing therapies,” said Dr. Suresh Durgam, Executive Vice President, Chief Medical Officer of Intra-Cellular Therapies. “In this Phase III study, lumateperone demonstrated a robust effect as an adjunctive treatment to antidepressants in patients with MDD who had inadequate response to antidepressant therapy. This study contributes to the growing body of evidence of lumateperone’s efficacy and safety across mood disorders.”