Intra-Cellular reports positive data for lumateperone in schizophrenia
Intra-Cellular (ITCI) announced “positive” topline data from the first part of an open-label safety switching study in which 302 patients with stable symptoms of schizophrenia were switched from standard-of-care antipsychotic medications to lumateperone with no dose titration of #lumateperone required for a 6-week treatment duration, then switched back to standard-of-care.
In this study, lumateperone was generally well tolerated with a favorable safety profile.
Statistically significant improvements from standard-of-care baseline were observed in body weight, cardiometabolic and endocrine parameters in patients with stable symptoms of schizophrenia when switched to lumateperone and worsened again when switched back to standard-of-care medication.
Additionally, treatment with lumateperone was not associated with the motor or cardiovascular disturbances often associated with other antipsychotic medications. Statistically significant improvement from baseline was observed in the Positive and Negative Syndrome Scale mean total score.
Greater improvements were observed in subgroups of patients with elevated symptomatology such as those with comorbid symptoms of depression and those with prominent negative symptoms.
You may recall last month ITCI reported positive data and that pushed shares higher. Today’s report should help push shares higher.
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