Neurocrine Biosciences has completed patient recruitment in the Phase IIb kinect study of NBI-98854, a vesicular mono-amine transporter 2 compound, to treat tardive dyskinesia.
The final subject is expected to be soon randomised in the parallel, double-blind study, which will assess twelve weeks of continuous dosing with capsule formulation of NBI-98854.
A total of 120 subjects with moderate to severe tardive dyskinesia and underlying schizophrenia or schizoaffective disorder are included in the placebo-controlled trial.
Neurocrine Biosciences chief medical officer Christopher O’Brien said, "Completing enrollment of this Phase IIb study is another milestone in the development of NBI-98854 and we look forward to sharing the top-line results shortly."
Two doses of once-daily NBI-98854 over a six-week placebo-controlled dosing period will be assessed in the kinect study, which involves administering placebo to half of the randomised subjects and one of two doses of investigational candidate to the remaining half.
In one of the two dosing groups of the investigational candidate, 50mg will be assessed for six weeks, while in the other group 100mg will be initially assessed for first two weeks then converting to 50mg for the final four weeks.
The placebo-controlled dosing period is followed by a six-week open label safety extension of NBI-98854 50mg administered once a day with additional abnormal involuntary movement scale (AIMS) assessments.
The study’s primary end point is comparison of placebo against active scores based on AIMS assessments at the end of sixth week.
The company expects topline data from the placebo-controlled portion of the trial in about ten weeks.