Positive Phase III results for Intra-Cellular’s Caplyta in schizophrenia

Intra-Cellular Therapies (Nasdaq: ITCI) has announced positive results from Study 304 evaluating the efficacy and safety of Caplyta (lumateperone) 42mg for the prevention of relapse in adult patients with schizophrenia.

The US biopharmaceutical company, which is focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, saw its shares close up 3.6% at $89.24 yesterday on the news.

“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.