Intra-Cellular Therapies announced positive topline results from its Phase 3 Study 304, evaluating lumateperone 42 mg (Caplyta) for the prevention of relapse in adult patients with schizophrenia. The randomized withdrawal trial demonstrated a statistically significant longer time to relapse in patients treated with lumateperone compared to placebo (p=0.0002), highlighting its potential as a maintenance treatment.
The multi-center, multi-national, double-blind, placebo-controlled study included an 18-week open-label phase, where patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met stabilization criteria then progressed to a 26-week double-blind treatment phase, randomized to either continue lumateperone 42 mg (N=114) or switch to placebo (N=114).
Significant Reduction in Relapse Risk
The primary endpoint, time to first symptom relapse, was significantly longer in the lumateperone group. There were 18 relapses (16.4%) in the lumateperone group versus 44 relapses (38.6%) in the placebo group. Treatment with lumateperone was associated with a 63% reduction in the risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]).
Secondary Endpoint Met
Lumateperone also met the key secondary endpoint, time to all-cause discontinuation during the double-blind phase (p=0.0007).
Safety and Tolerability
In terms of safety, lumateperone 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 rate of placebo was headache.
Expert Commentary
"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," said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies. "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."
About Caplyta (lumateperone)
Caplyta 42 mg is an oral, once-daily atypical antipsychotic approved for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder as monotherapy or adjunctive therapy with lithium or valproate. Its mechanism of action is unknown but may be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
