Neurocrine Biosciences (NBIX) Initiates NBI-98854 Phase IIb

December 18, 2012 4:14 PM EST Send to a Friend
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) has initiated a Phase IIb clinical trial (Kinect 2 Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. The design of this six-week Phase IIb study is a randomized, parallel, double-blind, placebo-controlled, dose titration trial of 90 subjects with moderate to severe tardive dyskinesia and underlying mood disorders, gastrointestinal disorders, and schizophrenia or schizoaffective disorder. Topline data is expected in mid-2013.

"The Kinect 2 Study for NBI-98854 will round out our dose response database with over 200 subject exposures to NBI-98854 for up to three months of duration," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences. "This extensive dataset will serve as the basis for our end of Phase II meeting with the FDA planned for the second half of 2013."

Kinect 2 Study Design

The Kinect 2 Study is a randomized, parallel, double-blind, placebo-controlled, dose titration Phase IIb clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with an underlying mood disorder (e.g., bipolar disorder), schizophrenia or schizoaffective disorder, or a gastrointestinal disorder with exposure to metoclopramide. This 90 subject study will assess once-daily NBI-98854 over a six-week placebo-controlled dosing period. Half of the randomized subjects will receive placebo and half will receive NBI-98854. The NBI-98854 dosing regimen will begin with a once-daily dose of 25mg for the initial two weeks. At the completion of the initial two weeks of dosing, based on certain efficacy and safety criteria, patients may be titrated to a once-daily 50mg dose, or continue on the once-daily 25mg dose for the following two-week period. At the completion of the second two weeks of treatment another efficacy and safety assessment is performed and patients may again be titrated to a once-daily 75mg, 50mg or 25mg dose for the final two weeks of treatment. The primary endpoint of the study is a comparison of placebo vs. active scores utilizing the Abnormal Involuntary Movement Scale (AIMS) at the end of week six.

The Company has designated a small panel of independent, blinded AIMS assessors to determine subject eligibility for the Kinect 2 Study. Prior to the randomization of any subject, a video of each potential subject's initial screening AIMS evaluation will be reviewed by a member of this panel to determine whether the individual has moderate to severe tardive dyskinesia. The independent panel is the sole determiner as to whether or not the subject meets the AIMS severity criteria to be eligible for the Kinect 2 Study. Additionally, this central panel will continue to serve as independent quality control monitors of the AIMS assessments during the entire course of the trial.

The Company has also enhanced the training and certification of the site specific, non-treating investigator to administer the AIMS assessments.


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