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news.US-based Neurocrine Biosciences has completed subject randomization of the Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Mono-Amine Transporter 2 (VMAT2) compound NBI-98854 in patients with tardive dyskinesia.
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The randomized, parallel-group, double-blind, placebo-controlled Kinect 3 trial includes around 240 subjects with moderate to severe tardive dyskinesia and an underlying diagnosis of mood disorder, schizophrenia or schizoaffective disorder.
During the trial, the initial six weeks of treatment includes an efficacy and safety assessment of 80mg and 40mg once-daily NBI-98854 against placebo and this will be followed by an additional 42 weeks of long-term safety assessment where all subjects are randomized in a blinded fashion to either 80mg or 40mg once-daily NBI-98854.
The company noted that topline efficacy data from the initial six week assessment is expected to be reported in the fourth quarter of 2015.
Neurocrine Biosciences chief medical officer Dr Christopher O’Brien said: "Completing enrollment of the Kinect 3 study is another milestone in the development of NBI-98854 and we look forward to sharing the top-line results next quarter."
The Phase III trial is using the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder or mood disorder.
Mean change from baseline in the abnormal involuntary movement scale (AIMS) as assessed by blinded central raters is the primary endpoint in the trial.
In addition to the Kinect 3 Study, the company has started a separate one-year open-label safety study of NBI-98854 to support the anticipated 2016 filing of a New Drug Application (NDA) in tardive dyskinesia.