Lumateperone Programs
Schizophrenia
Following guidance received from the U.S. Food and Drug Administration (FDA) in 2017, we intend to submit a new drug application (NDA) for lumateperone for the treatment of schizophrenia by mid-2018. A pre-NDA meeting with the FDA is scheduled to be held in late Q1 2018.
In November 2017, we announced that the FDA has granted Fast Track designation for lumateperone for the treatment of schizophrenia. We requested Fast Track designation for lumateperone based on clinical evidence that lumateperone has the potential to address the unmet medical need for the treatment of schizophrenia with significant improvements on several clinically significant safety parameters, including metabolic, motor and cardiovascular issues associated with many currently available antipsychotic agents.
In September 2017, we announced positive topline data from our 6-week open-label safety switching study with lumateperone in patients with schizophrenia. This trial evaluated stable patients with schizophrenia in an outpatient setting similar to common clinical practice and assessed both the impact of switching to lumateperone from standard-of-care antipsychotics (SOC) as well as the impact of switching back to SOC from lumateperone. In this trial, statistically significant improvements from SOC 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 SOC. These data are consistent with previous study results reflecting a safety profile similar to placebo in placebo-controlled trials with lumateperone in patients with acutely exacerbated schizophrenia and extend this favorable safety profile to this stable patient population. In this study, symptoms of schizophrenia did not worsen upon switch to lumateperone from SOC. Rather, statistically significant improvement from baseline was observed in the Positive and Negative Syndrome Scale (PANSS) mean total score. Notably, greater improvements were observed in subgroups of patients with comorbid symptoms of depression and those with prominent negative symptoms.
