Novel Agent for Schizophrenia Shows Promise
ORLANDO, Fla—A novel agent for the treatment of schizophrenia is producing promising results in efficacy and safety trials. Researchers from Intra-Cellular Therapies Inc., the developer of lumateperone, presented an overview of late-stage studies of the drug at Psych Congress 2018.
“Lumateperone is a first-in-class agent in development for schizophrenia that acts synergistically through serotonergic, dopaminergic, and glutamatergic systems,” researchers explained.
In 2 placebo-controlled clinical trials involving a total 785 participants, lumateperone showed significantly superior efficacy compared with placebo in score changes on the Positive and Negative Syndrome Scale (PANSS), researchers reported.
In a third trial that included 696 participants, lumateperone did not outperform placebo because of a high placebo response, according to a poster presented at Psych Congress. In all 3 clinical trials, however, the drug improved schizophrenia symptoms from baseline with the same trajectory and magnitude.
Lumateperone was well tolerated and demonstrated a favorable safety profile in the trials, researchers reported. Compared with risperidone, which was used as an active control in 2 of the studies, lumateperone performed significantly better in key safety and tolerability measures.
In an open-label safety switching study, patients with stable schizophrenia were switched from standard-of-care antipsychotics to lumateperone for 6 weeks and then switched back to standard-of-care antipsychotics. Researchers observed statistically significant improvements in body weight as well as cardiometabolic and endocrine parameters with lumateperone. When patients went back to their usual antipsychotics, the improvements were lost.
“Lumateperone represents a novel approach to the treatment of schizophrenia,” researchers concluded. “The lack of cardiometabolic and motor safety issues presents a safety profile differentiated from standard-of-care antipsychotic therapy.”
Intra-Cellular Therapies, which sponsored the studies, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the use of lumateperone as a treatment for schizophrenia.
Vanover K, Glass S, Kazaouer S, et al. Lumateperone (ITI-007) for the treatment of schizophrenia: overview of placebo-controlled clinical trials and an open-label safety switching study. Poster presented at Psych Congress 2018: October 25-28, 2018; Orlando, FL. Poster 131.