Positive Phase IIb Tardive Dyskinesia study with NBI 98854-Neurocrine Biosciences

Neurocrine Biosciences has announced that NBI 98854 showed a statistically significant and clinically meaningful reduction in Tardive Dyskinesia symptoms in the Phase IIb KINECT 2 study. The pre-specified primary endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6, at which point AIMS scores were reduced by 2.6 points in the NBI 98854 intention-to-treat (ITT) group compared to a reduction of 0.2 points in the placebo arm. Additionally, the responder rate was 49% in the ITT group compared to 18% in placebo. The improvement in Week 6 AIMS was also corroborated by the Clinical Global Impression�Tardive Dyskinesia (CGI-TD).

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 in this pre-specified key secondary efficacy endpoint. NBI 98854 was generally safe and well tolerated. During the six-week treatment period the frequency of treatment-emergent adverse events was 33% for placebo and 43% for NBI 98854.