Intra-Cellular Therapies (ITCI) Announces Publication of Lumateperone Pivotal Phase 3 Study in Bipolar Depression in The American Journal of Psychiatry

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 the publication of the results from its lumateperone monotherapy Phase 3 clinical trial (ITI-007-404). The article, "Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial,” was published online in The American Journal of Psychiatry and is available here.

“Bipolar depression represents the most prevalent and debilitating presentation of bipolar disorder. There is a critical need for more treatments that are effective and have favorable safety profiles,” said Dr. Gary S. Sachs, Associate Clinical Professor in Psychiatry at Harvard Medical School and Founding Director of the Bipolar Clinic and Research Program at Massachusetts General. “The strong efficacy and impressive safety results reported in this trial for a broad patient population position lumateperone as a potentially important advancement in the treatment of this disorder.”

“We are excited about the robust results seen across our bipolar depression program. The study reported on today, Study 404, our monotherapy study, along with Study 402, our adjunctive study with lithium or valproate form the basis of our supplemental NDAs under FDA review. If approved, we plan to to launch immediately and look forward to bringing CAPLYTA to market for the treatment of bipolar depression,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

Study 404 assesed the efficacy and safety of lumateperone as monotherapy in patients with bipolar I or bipolar II disorder experiencing a major depressive episode (bipolar depression). This global study randomized 381 patients with moderate to severe depression symptoms to receive placebo or lumateperone 42 mg for 6 weeks. The primary endpoint was the efficacy of 42 mg/day of lumateperone compared with placebo, measured by mean change from baseline to day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.

In this clinical trial, treatment with lumateperone resulted in a substantial reduction in depressive symptoms. lumateperone 42mg was associated with a statically signficant greater reduction in MADRS score from baseline to day 43 (drug placebo difference -4.6 (P<0.0001; effect size = 0.56). Lumateperone 42 mg signficantly improved MADRS Total Score compared with placebo as early as week 1, the first time point measured, with continuing improvement throughout the study. Additionally, significant improvement in MADRS Total Score in the lumateperone group compared with placebo group at Day 43 was observed both in patients with bipolar I disorder and in those with bipolar II disorder.

Improvements were also seen in important secondary endpoints. Lumateperone 42 mg met the key secondary endpoint of statistically significant improvement on the CGI-BP-S Total Score (p<0.0001; effect size = 0.46) and on the CGI component that specifically assesses depression (CGI-BP-S Depression Score; p<0.001; effect size = 0.50).

Results support the favorable safety and tolerability profile of lumateperone. The most commonly reported adverse events occurring for lumateperone 42mg in >5% of patients and twice the rate in the placebo group were somnolence and nausea.

Lumateperone continues to report a favorable safety profile in important adverse events commonly asociated with antipsychotic therapy. Weight changes were similar to placebo with no notable changes in metabolic parameters including fasting glucose, cholesterol, triglycerides, insulin or prolactin levels. Incidence of extrapyramidal symptom related events were low and similar to placebo.

CAPLYTA® (lumateperone) is indicated for the treatment of schizophrenia in adults and has not been approved for other uses. CAPLYTA is available in 42 mg capsules.

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