Intra-Cellular Therapies, a biopharmaceutical company focused on central nervous system (CNS) disorders, announced positive results from the Phase 3 Study 304 of Caplyta (lumateperone) for the treatment of adult patients with schizophrenia.
Caplyta is approved for the treatment of schizophrenia in adults. It is also approved for managing depressive episodes in adults with bipolar depression, either as monotherapy or in combination with lithium or valproate.
The drug received its initial US Food and Drug Administration (FDA) approval in late 2019.
Study 304, a withdrawal trial, is part of Intra-Cellular’s post-marketing commitment to the FDA, a standard requirement for antipsychotic medications.
It was a multicentre, multinational, randomised, double-blind, placebo-controlled study of lumateperone for preventing relapse in adults with schizophrenia.
The study lasted about 47 weeks and included an 18-week open-label phase where patients were treated with lumateperone 42 mg per day.
The patients were randomised to either continue with lumateperone 42 mg or switch to a placebo for up to 26 weeks, or until a relapse occurred.
The primary endpoint was the time to first symptom relapse, while the key secondary endpoint was the time to all-cause discontinuation during the double-blind phase.
Patients receiving Caplyta had a significantly longer time to relapse during the double-blind phase compared to those on placebo.
Overall, there were 18 relapses in the lumateperone group compared with 44 relapses in the placebo group. Treatment with Lumateperone reduced the risk of relapse by 63% compared to placebo.
Caplyta also met the key secondary endpoint of time to all-cause discontinuation during the double-blind phase.
Overall, the schizophrenia treatment was generally safe and well tolerated.
Intra-Cellular Therapies executive vice president and chief medical officer Suresh Durgam said: “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 randomised withdrawal trial, demonstrated efficacy along with favourable safety and tolerability which support the benefit of continued long-term treatment with lumateperone.”
Lumateperone is also being studied for the treatment of major depressive disorder (MDD), as well as other psychiatric and neurological disorders.
The company plans to submit a marketing application for lumateperone in MDD in Q4 2024.
In September, Bristol Myers Squibb received the FDA approval for Cobenfy (xanomeline and trospium chloride) to treat schizophrenia in adults.
