Intra-Cellular Therapies (NASDAQ: ITCI) Announces Positive Results from Study 304 on CAPLYTA for Schizophrenia Patients

Intra-Cellular Therapies, Inc. disclosed on November 5, 2024, that they have received positive topline results from Study 304 regarding the evaluation of CAPLYTA (lumateperone) for the prevention of relapse in patients grappling with schizophrenia. The company revealed this information through a press release accompanying a Form 8-K filing with the Securities and Exchange Commission.

The study demonstrated a statistically significant outcome, with patients treated with lumateperone showcasing a notably prolonged time to relapse compared to those on a placebo regimen. In the lumateperone group, there were 18 relapses (16.4%), in contrast to 44 relapses (38.6%) in the placebo group. The treatment displayed a 63% reduction in the risk of relapse versus placebo, emphasizing the potential benefits of extended lumateperone administration.

The phase 3 trial Study 304, a randomized withdrawal trial, focused on the efficacy and safety of lumateperone 42 mg for schizophrenia patients. The safety profile of lumateperone was generally favorable, with the most commonly reported adverse event being headache.

CAPLYTA (lumateperone) is indicated as a treatment for schizophrenia and depressive episodes linked with bipolar I or II disorder in adults. The medication appeared to be well-tolerated, raising hopes for its extended use in patient care.

Intra-Cellular Therapies, a biopharmaceutical organization dedicated to developing and marketing therapeutics for central nervous system disorders, has been in the forefront of research related to psychiatric and neurological conditions. Dr. Suresh Durgam, the company’s Executive Vice President and Chief Medical Officer, expressed satisfaction with the results, emphasizing the importance of managing symptoms and preventing relapses in patients with schizophrenia.

The overarching success of Study 304 could potentially pave the way for expanded treatment options in the management of schizophrenia and related disorders. As the company progresses with its clinical trials and developments, the impact of these positive outcomes on patient care continues to remain under close observation.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Intra-Cellular Therapies’s 8K filing here.

Intra-Cellular Therapies Company Profile

Intra-Cellular Therapies, Inc, a biopharmaceutical company, focuses on the discovery, clinical development, and commercialization of small molecule drugs that address medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms in the central nervous system (CNS) in the United States.