Neurocrine Posts Further TD Data

Neurocrine Biosciences has posted initial results from a Phase IIb study of NBI-98854, a small molecule VMAT2 inhibitor, in development for tardive dyskinesia. The treatment showed an excellent safety profile and a clinically meaningful reduction in tardive dyskinesia symptoms in as long as 12 weeks of continuous dosing. This is the second study reporting out this week that demonstrates the potential of NBI-98854 as a safe and highly effective therapy for tardive dyskinesia sufferers. Both of these studies will serve as the foundation for an End of Phase II meeting later this year.

 

The Phase IIb study was a randomized, parallel, double-blind, placebo-controlled trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia or schizoaffective disorder. The study assessed NBI-98854 through a six-week placebo-controlled dosing period. Subsequent to the placebo-controlled dosing period, all subjects were eligible to enter a six-week open-label safety extension of 50 mg of NBI-98854 administered once daily, followed by a four-week washout period.

 

NBI-98854 was generally safe and well tolerated in the Kinect study. During the 12-week treatment period, the frequency of treatment-emergent adverse events was 40% for NBI-98854, similar to previous clinical trials. There were no drug-related serious adverse events. The most common treatment-emergent adverse event during the entire twelve-week period was urinary tract infection in six subjects (5.9%) on NBI-98854, which were assessed as not related to the study drug by the investigators. All other adverse events occurred at less than a 3% frequency.