Intra-Cellular Therapies reveals promising phase 3 data for schizophrenia relapse prevention

Intra-Cellular Therapies has reported positive results from a phase 3 trial evaluating Caplyta (lumateperone) as a maintenance treatment to prevent relapse in adults with schizophrenia.

The study showed a significant improvement in time to relapse for patients on lumateperone compared to those receiving a placebo, supporting the potential of lumateperone in potential long-term management of schizophrenia.

The study, called Study 304, was designed as a randomized withdrawal trial. Patients who had stabilized on lumateperone were either continued on the drug or switched to a placebo. Results revealed that 16.4% of patients on lumateperone experienced a relapse, compared to 38.6% on placebo, reflecting a 63% reduction in relapse risk for those on the treatment.

Lumateperone also met its key secondary goal, showing a longer time to discontinuation due to any cause compared to placebo. Safety data indicated the treatment was generally well tolerated, with headache being the most common side effect, reported at a rate significantly higher than placebo.

Already approved for treating schizophrenia and bipolar depression in adults, Caplyta is being further explored for its potential benefits in other psychiatric and neurological conditions.