Intra-Cellular Therapies highlights lumateperone presentations at the 58th annual Meeting of the American College of Neuropsychopharmacology.

Intra-Cellular Therapies, Inc. announced data featured during the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) held in Orlando, FL, December 8-11, 2019 included: Efficacy and Safety of Lumateperone 42 mg in the Treatment of Schizophrenia: A Pooled Analysis of Randomized Clinical Trials� (Poster W201)- This poster highlighted the clinical results of lumateperone 42 mg, including its safety and tolerability profile from the short-term controlled studies of lumateperone in the treatment of patients with acute exacerbations of schizophrenia. The poster included additional post-hoc pooled analyses that found lower rates of MetSy in patients treated with lumateperone than in patients treated with risperidone. In these double-blind, placebo-controlled studies of 4 to 6 weeks duration, patients were randomized to either lumateperone 42mg (n=406), risperidone 4mg (n=255) or placebo (n=412). The percentage of patients meeting criteria for MetSy at baseline was similar across groups (18.2% for lumateperone, 19.2% for risperidone and 17.0% for placebo). At study endpoint, fewer patients on lumateperone met the MetSy criteria compared with the percentage on risperidone (15.0% v. 24.7%). Among those patients with MetSy at baseline, the percentage who no longer met criteria for MetSy after study treatment was nearly twice as high among patients treated with lumateperone as among patients treated with risperidone (45.9% v. 24.5%). Among patients without MetSy at baseline, the percentage that developed MetSy during study treatment with lumateperone was half that in risperidone-treated patients (6.3% v. 12.6%).

�Metabolic Syndrome is a highly prevalent set of risk factors among patients with schizophrenia and is associated with many commonly prescribed antipsychotics,� said Dr. Christoph Correll, Professor of Psychiatry and Molecular Medicine at the Zucker School of Medicine at Hofstra/Northwell, New York. �Previous data have indicated that lumateperone is associated with effects similar to placebo in short-term trials on body weight and cardiometabolic parameters, including levels of blood glucose, insulin, and cholesterol. Moreover, in a switch safety study, lumateperone was associated with improvements in several important cardiometabolic parameters. These new safety analyses in the broader context of a well-recognized clinical entity, the Metabolic Syndrome, which is a well-established marker for overall cardiovascular risk, are encouraging.�

�Additional Results from a 12-Month Open-Label Safety Study of Lumateperone (ITI-007) in Patients with Stable Symptoms of Schizophrenia� (Poster W203). : Additional results from the lumateperone long-term safety study were presented. The data presented showed the safety of long-term lumateperone treatment was consistent with previously reported studies and associated with a low risk of metabolic, EPS, and prolactin side effects. Patients with stable schizophrenia symptoms continued to show improvement in PANSS scores with lumateperone treatment throughout the 1-year open-label study. Furthermore, in patients with schizophrenia and comorbid depression symptoms at baseline lumateperone 42 mg improved depressive symptoms.