Additional results from long-term open label safety study of lumateperone to treat schizophrenia

Intra-Cellular Therapies, Inc. announced additional results from its open-label safety switching study (Study 303) assessing the effects of long-term administration of lumateperone, an investigational drug, in patients with stable symptoms of schizophrenia. Results were also presented on the improvements in symptoms of depression in patients with moderate to severe co-morbid depression. The data were presented at the 2019 Congress of the Schizophrenia International Research Society (SIRS), which was held in Orlando, Florida, April 10-14, 2019.

Poster #S117 entitled “Favorable Long-Term Safety Profile of Lumateperone (ITI-007): Results from a 12-Month Open Label Safety Study in Patients with Stable Symptoms of Schizophrenia” was presented on Saturday April 13th. Study 303 was conducted to assess the long-term effects of treatment with lumateperone on weight and other safety parameters and to observe the impact of switching from standard-of-care (SOC) antipsychotic medications. The poster presented at SIRS provided additional detail on the initial results presented last year showing that lumateperone, administered for up to one year, was generally well tolerated and exhibited statistically significant improvements from baseline on key safety measures of body weight, cardiometabolic and endocrine parameters, without motor side effects often associated with other antipsychotic medications.

In addition, patients treated with lumateperone remained stable with respect to their symptoms of schizophrenia upon switching from SOC. Based on its pharmacology and prior clinical results The company believes lumateperone may provide advantages in the treatment of the broad symptoms associated with schizophrenia including depressive symptoms. Thus, additional objectives of the study included determining the effectiveness of lumateperone at treating depressive symptoms in patients with co-morbid depression. The antidepressant effects of lumateperone (ITI-007 60 mg) were assessed using the Calgary Depression Scale for Schizophrenia (CDSS), a validated scale to asses depression in patients with schizophrenia. In patients with moderate-to-severe depression symptoms at baseline (CDSS?6; N=55), lumateperone treatment was associated with marked improvement in CDSS scores. Specifically, mean CDSS scores decreased by approximately 60% from 7.4 (baseline) to 3.1 (Day 300). In addition, 60% of patients met CDSS response criteria (50% improvement from baseline) by Day 75 and this response rate was maintained through Day 300. Importantly, a similar magnitude of CDSS improvement was seen regardless of concurrent antidepressant therapy.

Comment; lumateperone has a PDUFA date of 27 September 2019.