Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company specializing in treatments for central nervous system (CNS) disorders, has announced positive results from Study 304, which evaluated the efficacy and safety of lumateperone 42 mg for preventing relapse in adults with schizophrenia.
“Schizophrenia is a chronic, serious mental illness marked by recurring acute psychotic episodes that can worsen long-term outcomes,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies. “Controlling symptoms and preventing relapses are essential for improving patient outcomes, and we are pleased that Study 304 demonstrated the efficacy, safety, and tolerability of long-term treatment with lumateperone.”
The study’s primary endpoint—time to relapse during the double-blind treatment phase—showed significant improvement with lumateperone compared to placebo (p=0.0002). The relapse rate was 16.4% (18 patients) in the lumateperone group versus 38.6% (44 patients) in the placebo group, reflecting a 63% reduction in relapse risk for lumateperone (hazard ratio [95% CI] = 0.37, [0.22, 0.65]).
Lumateperone also met the key secondary endpoint, time to all-cause discontinuation during the double-blind phase (p=0.0007).
The treatment was generally safe and well-tolerated, with headache being the most commonly reported adverse event at a rate of at least 5% and twice that of placebo.
