Intra-Cellular Therapies Announces Top Line Results for Two Bipolar Studies

Jul 13, 2019 | CNS, Lumateperone, Mental Health

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Intra-Cellular Therapies, Inc. posted varied results in two phase 3 clinical trials evaluating lumateperone as monotherapy for major depressive episodes associated with bipolar disorder.

Study 404

Study 404 was conducted globally, including in the United States, and randomized 381 patients to lumateperone 42 mg or placebo. The drug met the primary endpoint for improvement in depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), and it’s key secondary endpoint, the Clinical Global Impression Scale for Bipolar for Severity of Illness Total Score.

Additionally, the study revealed statistically significant improvements in responder and remission rates and within patient subgroups.

Study 401

Conducted only in the U.S., 554 patients were randomized to lumateperone 42 mg or 28 mg or placebo. Neither does meet the primary endpoint of statistical separation from placebo in the MADRS total score. There was a high placebo response in the trial, Intra-Cellular reported.

Lumateperone Well Tolerated

In both studies, lumateperone was well tolerated, with a favorable safety profile and low discontinuation rates due to treatment-emergent adverse events of both doses, according to a statement form Intra-Cellular. The rates of akathisia, restlessness, and extrapyramidal symptoms combined were less than 1% and similar to placebo in both trials.

Lumateperone is presently being evaluated by the US Food and Drug Administration as a treatment for schizophrenia. 

What is Lumateperone? 

It is Intra-Cellular’s lead product candidate—a first-in-class molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate—three neurotransmitter pathways implicated in severe mental illness. Unlike existing schizophrenia treatments, lumateperone is a dopamine receptor phosphoprotein modulation, or DPPM, acting as a pre-synaptic partial agonist and post-synaptic antagonist at the D2 receptor.

They believe that this mechanism, along with potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation, contributes to the efficacy of ITI-007 across a broad array of symptoms, with improved psychosocial function and favorable tolerability. This compound has the potential to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases.

Our clinical development program for the treatment of schizophrenia with lumateperone includes three large randomized, double-blind, placebo-controlled trials—studies ‘005, ‘301, and ‘302. In two studies, the efficacy of ITI-007 60 mg was demonstrated, showing a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale or PANSS total score. Across all three studies, ITI-007 was found to be well tolerated with a safety profile similar to placebo.


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