On Tuesday, Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) reported results from Study 304 of lumateperone 42 mg for the prevention of relapse in adult patients with schizophrenia.
On the primary endpoint, the time to relapse during the double-blind treatment phase was significantly longer in patients receiving lumateperone than in those receiving placebo (p=0.0002).
There were 18 relapses (16.4%) in the lumateperone group versus 44 relapses (38.6%) in the placebo group.
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Treatment with lumateperone was associated with a 63% reduction in risk of relapse versus placebo.
Lumateperone also met the key secondary endpoint, time to all-cause discontinuation during the double-blind phase (p=0.0007).
Lmateperone was generally safe and well tolerated. The most commonly reported adverse event observed at a rate greater than or equal to 5% and twice the placebo rate was headache.
"Schizophrenia is a chronic, serious mental illness characterized by the occurrence of acute psychotic episodes that cumulatively worsen disease prognosis. The control of symptoms and the prevention of relapses is critical to improving long-term patient outcomes. We are very pleased that the results from Study 304, a randomized withdrawal trial, demonstrated efficacy along with favorable safety and tolerability which support the benefit of continued long-term treatment with lumateperone," said Dr. Suresh Durgam, executive vice president and chief medical officer of Intra-Cellular Therapies.
Caplyta (lumateperone) is indicated in adults for schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
Earlier this year, data from Studies 501 and 502 of lumateperone 42 mg as adjunctive therapy to antidepressants for major depressive disorder showed a statistically significant and clinically meaningful reduction in the Montgomery and Asberg Depression Rating Scale total score compared to placebo at Week 6.
Price Action: ITCI stock is up 0.72% at $86.79 at last check Tuesday.
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