ITCI - Intra-Cellular Therapies Announces Presentations at Psych Congress 2023 Including Positive Results from Study 403 in Mixed Features | Benzinga
NEW YORK, Sept. 11, 2023 (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 several CAPLYTA data presentations at the 2023 Psych Congress held September 6 - 10, 2023 in Nashville.
"We are very excited to share additional lumateperone data including the positive results from Study 403. Study 403 is the first prospective double-blind placebo-controlled study in patients with either MDD or bipolar depression exhibiting mixed features based on DSM-5 criteria," said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies.
"Patients with mixed features have greater severity of illness, respond poorly to antidepressants and present a high cost to the healthcare system. This is a very important study in the field of psychiatry and further supports lumateperone's broad potential in mood disorders," said Dr. Roger McIntyre, Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada.
Poster 94: "Lumateperone Treatment for Major Depressive Episodes with Mixed Features in Major Depressive Disorder and Bipolar I or Bipolar II Disorder"
In this study, lumateperone 42mg was statistically significant on the primary endpoint of symptom reduction on the Montgomery Asberg Depression Rating Scale (MADRS) for the combined mixed features patient population of MDD and bipolar depression ((5.7 point reduction v. placebo; p<0.0001; Cohen's d effect size (ES) of 0.64) and the individual patient populations of MDD with mixed features (5.9 point reduction v. placebo; p<0.0001; ES= 0.67) and bipolar depression with mixed features (5.7 point reduction v. placebo; p<0.0001; ES= 0.64). Lumateperone 42mg also met the key secondary endpoint by demonstrating a statistically significant and clinically meaningful reduction in the Clinician's Global Impression scale or CGI compared to placebo at Week 6 in these three populations.
Lumateperone was generally safe and well tolerated, with a side effect profile consistent with prior lumateperone trials. The most common adverse events in the study were somnolence, dizziness and nausea.
There were no notable changes in weight, body mass index, or waist circumference and no clinically relevant changes in metabolic parameters.
Other presentations highlighting important aspects of CAPLYTA's efficacy and safety in the treatment of a broad patient population with bipolar I and bipolar II disorder as monotherapy and as adjunctive therapy:
- Poster 67: "Changes in Metabolic Parameters Associated With Lumateperone in Late-Phase Clinical Trials for the Treatment of Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder"
- Poster 98: "Evaluation of Mania and Hypomania in Late-Phase Clinical Trials of Lumateperone in the Treatment of Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder"
- Poster 132: "Lumateperone in the Treatment of Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: Evaluation of Extrapyramidal and Motor Symptoms in Late-Phase Clinical Trials"
- Poster 152: "Efficacy of Lumateperone in Pooled Short-Term Late-Phase Clinical Trials for the Treatment of Major Depressive Episodes Associated With Bipolar II Disorder"
CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
Important Safety Information
Boxed Warnings:
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk ...