VMAT2 UpdateThe Company has completed enrollment in Kinect 2, a Phase IIb study of its VMAT2 inhibitor, NBI-98854. This study is a 90 subject, placebo-controlled, double-blind, parallel-design, multiple-dose, six-week study assessing NBI-98854 in doses up to 75mg once-a-day against placebo in tardive dyskinesia patients with underlying mood disorders, schizophrenia and schizoaffective disorders, and gastrointestinal disorders. The primary endpoint is the Abnormal Involuntary Movement Scale (AIMS) at the end of the six weeks of dosing. The video AIMS will be scored by blinded central reviewers who are movement disorder neurologists. This study recently completed screening and randomization of subjects, and top-line data from this study is expected in December of 2013.
In 2014, the Company intends to initiate another clinical study of NBI-98854 in tardive dyskinesia patients. This study is currently in the design phase, and the results of the Kinect and Kinect 2 Studies will serve to inform the ultimate design of this clinical trial. The primary endpoint in this study will be the AIMS assessed by blinded central reviewers who are movement disorder neurologists.
The Company is currently completing two Phase I studies for NBI-98854 assessing drug-drug interactions as well as the impact of hepatic impairment on drug metabolism.
Additionally, the Company is conducting preclinical studies to support the advancement of NBI-98854 into clinical trials for individuals suffering from Tourette's syndrome. Upon successful completion of these preclinical studies, the Company anticipates entering Phase I and Phase II clinical studies in 2014.
Conference Call and Webcast Today at 5:00PM Eastern Time
Neurocrine will hold a live conference call and webcast today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants can access the live conference call by dialing 866-952
|SOURCE Neurocrine Biosciences, Inc.|
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