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Neurocrine Tourette Phase 2 trial misses endpoint

May 23, 2017

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the initial Phase II Tourette syndrome T-Force GREEN study of INGREZZA®(valbenazine), a small molecule VMAT2 inhibitor, did not meet its primary endpoint. The pre-specified primary endpoint was the change-from-baseline between the placebo and active groups in the Yale Global Tic Severity Scale (YGTSS) at Week 6 in the intent-to-treat (ITT) population.

Exposure-response analysis showed that the selected doses for this placebo-controlled Phase II study were below the therapeutic range for adequate tic reduction in the majority of pediatric subjects. For the subset of subjects with pharmaceutical exposure in the appropriate range, there was a substantial reduction in tics (e.g., -11.3 to -13.7 points on the YGTSS).  For subjects with sub-therapeutic exposure, tic reduction was comparable to placebo (e.g., -4.7 to -8.3 points on the YGTSS).  In this study, adverse events were consistent with those observed in previous INGREZZA studies.  There were a total of four discontinuations due to adverse events, two in each of the placebo and INGREZZA arms.

“This study showed that we underestimated the INGREZZA dose needed for the pediatric population but also provided us with a clear-cut view into the level of dosing required for future studies,” said Christopher F. O’Brien, Chief Medical Officer of Neurocrine. “We have developed a complete exposure-response model from this study that we believe accurately defines the appropriate dose-range to be tested in the next clinical study that will be started later this year.  We were very pleased with the conduct of the T-Force GREEN study in that we were able to identify the appropriate pediatric subjects for the clinical trial, and the investigators demonstrated consistent and appropriate application of the Yale Global Tic Severity Scale.”


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