Positive Phase 3 Results: Lumateperone as Adjunctive Treatment for MDD in Study 501

Intra-Cellular Therapies, Inc. has announced that their drug lumateperone, at a dosage of 42 mg, has shown significant progress in treating major depressive disorder (MDD) when used alongside antidepressants. The results from Study 501 indicate that lumateperone not only outperformed placebos in reducing depressive symptoms but also maintained its efficacy from the first week of treatment. The drug demonstrated a mean reduction of 4.9 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) at the sixth week, a substantial improvement with a large effect size of 0.61.

In addition to MADRS, lumateperone also significantly reduced scores on the Clinical Global Impression Scale for Severity of Illness (CGI-S), another key measure, with an effect size of 0.67. The drug's benefits were evident early in the treatment process and continued throughout the study duration. Patient-reported outcomes via the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) also supported the drug's efficacy, showing significant improvements in depressive symptom severity.

The study involved 485 patients who were randomly assigned to receive either lumateperone 42 mg or a placebo in conjunction with antidepressants. The baseline MADRS scores for both groups were comparable, and the drug was found to be safe and well-tolerated, with adverse events being mild to moderate and resolving quickly. The most common side effects were dry mouth, fatigue, and tremor.

Dr. Sharon Mates, CEO of Intra-Cellular Therapies, highlighted the importance of these findings, stating that lumateperone could become a first-choice treatment for mood disorders due to its robust efficacy and favorable safety profile. The company is committed to providing better treatment options for patients with major neuropsychiatric conditions and is working to expand the use of lumateperone.

Dr. Suresh Durgam, Chief Medical Officer, emphasized the need for effective treatments with good safety profiles for MDD, given that many patients do not respond well to initial therapies or suffer from side effects of existing treatments. The study's results contribute to the growing evidence supporting lumateperone's efficacy and safety across mood disorders.

Major Depressive Disorder is a prevalent condition affecting millions of adults annually, causing significant disability and impacting quality of life. Many patients fail to achieve remission with first-line treatments, making the development of new and effective therapies critical.

The company plans to discuss the Study 501 results in a conference call and webcast, and they are also anticipating results from another Phase 3 study, Study 502, later in the year. Lumateperone is currently approved for the treatment of schizophrenia and depressive episodes associated with bipolar disorders but is still under investigation for MDD and other conditions.