Intra-Cellular Therapies Unveils Exciting Data on Lumateperone at ECNP
Intra-Cellular Therapies Presents Innovative Data at European Congress
Oral and poster presentations showcased findings from Study 501, which examined lumateperone 42 mg as supplementary treatment for major depressive disorder (MDD).
Another highlight includes poster presentations detailing post-hoc analyses from Study 403, which assessed a designated patient group with MDD or bipolar depression exhibiting anxious distress.
Intra-Cellular Therapies, Inc. (NASDAQ: ITCI), a biopharmaceutical firm dedicated to developing therapies for central nervous system (CNS) disorders, recently announced significant results from the Phase 3 Study 501 during the 37th European College of Neuropsychopharmacology (ECNP) Congress, held in Milan.
Dr. Suresh Durgam, the Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies, expressed satisfaction regarding the positive data presented on lumateperone, highlighting its beneficial role as an adjunctive therapy for MDD. "The robust efficacy shown by lumateperone, combined with a strong safety profile, establishes CAPLYTA as a potentially vital medication for treating MDD across various patient populations," Dr. Durgam stated.
Here are the detailed presentation specifics:
Highlights from Study 501
Oral Presentation: "Adjunctive Lumateperone Significantly Improves Symptoms of Major Depressive Disorder: Topline Results From a Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial." Scheduled for Monday, 15:00 - 16:20 CEST.
Poster Presentation: P2127 – "Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder: Results From a Randomised, Double-Blind, Phase 3 Trial." On Monday, from 12:35 to 14:00 CEST.
Insights from Study 403
Poster Presentation P2113 focuses on "Lumateperone in the Treatment of Patients With Major Depressive Disorder and Bipolar Disorder With Anxious Distress and Mixed Features," occurring Monday from 12:35 to 14:00 CEST.
Another poster, P2096, evaluates "Lumateperone in the Treatment of Major Depressive Disorder and Bipolar Depression With Mixed Features: Efficacy Across Symptoms," scheduled for the same timeframe.
In Study 501, lumateperone met its primary endpoint by demonstrating a significant change from baseline as measured by the Montgomery Asberg Depression Rating Scale (MADRS) total score at Week 6 compared to placebo, showing a reduction of 4.9 points (p < 0.0001; Cohen’s d effect size (ES)= 0.61). This positive effect was noted as early as Week 1, with continued improvement throughout the trial. Moreover, significant secondary endpoints were achieved in clinician-rated metrics on the Clinical Global Impression Scale for Severity of Illness (CGI-S).
A patient-reported measure, the Quick Inventory of Depressive Symptomatology Self Report scale (QIDS), also indicated robust improvements in depressive symptoms (p < 0.0001). The safety profile was similar to previous studies investigating lumateperone for bipolar depression and schizophrenia, highlighting stable metabolic parameters including glucose and cholesterol levels.
Study 502 further corroborated these findings, as lumateperone 42 mg plus an antidepressant met both primary and key secondary efficacy endpoints, proving safe and well-tolerated in patients not responding sufficient enough to traditional antidepressant therapy. Additional details from Study 502 will be revealed at future conferences.
Study 403 further elaborated on lumateperone's efficacy in patients with either MDD or bipolar depression with mixed features, shedding light on these intricate diagnoses through targeted analyses.
Poster #2113 discussed a post-hoc analysis focused specifically on patients meeting DSM-5 criteria for anxious distress, further demonstrating lumateperone’s potential in alleviating depressive symptoms and severity in this high-risk group.
Additionally, Poster #2096 presented a breakdown of MADRS individual items, illustrating the broad-spectrum efficacy of lumateperone across various depressive symptoms.
Understanding Major Depressive Disorder
Major Depressive Disorder (MDD) affects millions annually in the U.S., leading to profound effects on individuals' quality of life and functional capacity. Symptoms may include deep-seated sadness, hopelessness, and cognitive impairment. Unfortunately, a significant number of patients struggle with treatment resistance using first-line options.
CAPLYTA® (lumateperone) is currently approved for use in treating schizophrenia and depressive episodes associated with bipolar disorder. It provides an essential addition to the therapeutic landscape for patients struggling with complex mood disorders.
Safety Information for Patients
CAPLYTA comes with important safety warnings. Particularly, elderly patients with dementia-related psychosis are advised against its use due to the increased risk of death. Additionally, patients should be closely monitored for potential side effects, including the increase in suicidal thoughts commonly associated with antidepressants.
Frequently Asked Questions
What is lumateperone used for?
Lumateperone (CAPLYTA) is primarily indicated for treating schizophrenia and depressive episodes linked to bipolar disorder.
What were the key findings from Study 501?
Study 501 demonstrated that lumateperone significantly improves MDD symptoms compared to placebo, achieving crucial efficacy metrics.
How does lumateperone compare to traditional antidepressants?
Lumateperone shows robust efficacy while maintaining a favorable safety and tolerability profile, making it a promising adjunct treatment option.
Are there any notable side effects of CAPLYTA?
Common side effects include sedation, dizziness, and nausea. Patients should be monitored for these and other potential adverse reactions.
What are the next steps for Intra-Cellular Therapies?
The company plans to submit a supplemental New Drug Application (sNDA) for lumateperone's role in treating MDD later this year.
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