Neurocrine Announces Successful Completion of Phase Ib T-Force Study of VMAT2 Inhibitor NBI-98854 in Adolescents and Children with Tourette Syndrome

Neurocrine Biosciences, Inc. NBIX announced today that it has successfully completed the Phase Ib T-Force study of NBI-98854 (valbenazine), a once-daily, highly selective, small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor. The T-Force Study evaluated several doses of valbenazine in children and adolescents with Tourette syndrome over two weeks of treatment. Valbenazine was generally safe and well tolerated. The Yale Global Tic Severity Scale was also assessed and after two weeks of treatment showed a mean reduction of 31% from baseline scores, with over half of the subjects considered clinical responders. The Company intends to initiate a placebo-controlled Phase II study of valbenazine in children and adolescents with Tourette syndrome during the first half of 2016. "We are very pleased with the pharmacokinetic profile as well as the safety and tolerability demonstrated by valbenazine in the T-Force study evaluating children and adolescents with Tourette syndrome," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine. "The 31% reduction in Tourette syndrome symptoms as measured by the Yale Global Tic Severity Scale after just two weeks of dosing was corroborated by an improvement in Tourette symptomology as assessed by the treating physician using the Clinical Global Impression in Tourette Syndrome Scale. We will use the PK data to support pediatric dose selection and look forward to initiating a placebo-controlled Phase II study in children and adolescents with Tourette's in 2016." T-Force Study Design The T-Force study was an open-label, multiple ascending dose, pharmacokinetic and pharmacodynamic, study that evaluated the safety, tolerability and exposure-response of valbenazine in children and adolescents with Tourette syndrome. A total of 28 subjects were evaluated over 14 days of once-daily dosing followed by seven days off-drug at approximately 10 study centers in the United States. The study was divided into two dosing groups consisting of children (ages 6-11) and adolescents (ages 12-18), and each age group was further divided into three dosing cohorts. Subsequent dose escalations for children and adolescents were based, in part, on the pharmacokinetic and safety data from the previous cohort in each age group. Additionally, the patients' Tourette symptoms were evaluated weekly via the Yale Global Tic Severity Scale, the Premonitory Urge for Tics Scale as well as an overall Clinical Global Impression in Tourette Syndrome Scale.