Neurocrine Biosciences Posts Positive Results in Tardive Dyskinesia

Neurocrine Biosciences has posted results from the Phase IIb Kinect 2 study of NBI-98854, a small molecule VMAT2 inhibitor. The company reports that it showed a statistically significant and clinically meaningful reduction in tardive dyskinesia symptoms. The pre-specified primary endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 as assessed by central blinded video raters.

The improvement in Week 6 AIMS was also corroborated by the Clinical Global Impression–Tardive Dyskinesia (CGI-TD). Treating clinicians determined that approximately 67% of the subjects taking NBI-98854 were “much improved” or “very much improved” at Week 6 compared to only 16% of the placebo subjects. The Kinect 2 study randomized 102 subjects.

The data from the study allows the company to submit an End of Phase II meeting request with the FDA, as well as finalize the initial draft of a Phase III protocol. The company plans to file both in 1H14. Data from the Kinect 2 study will be integrated with the Kinect study data to inform the ultimate design of the next study, Kinect 3. The company plans to work with its consultants and scientific advisors to expand and refine the pharmacokinetic/pharmacodynamic models as well as to complete the remaining safety and efficacy analyses from both Kinect and Kinect 2. These data will form the basis for an End of Phase II briefing package along with the proposed Phase III protocol.