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Neurocrine Biosciences, Inc.

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"Evaluation of Valbenazine in adults with Tourette syndrome is another important step in fully exploring its potential in movement disorders," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences. "We look forward to our T-Force study readout of children and adolescents with Tourette's during this quarter, and our anticipated NDA filing of NBI-98854 for tardive dyskinesia in 2016."
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Source: press release, 10/20/15. http://phx.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=...

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Neurocrine Announces Expansion Of VMAT2 Inhibitor Program With Initiation Of Tourette Syndrome Clinical Study

NBI-98854 TO BE EVALUATED FOR BOTH CHILDREN AND ADOLESCENTS IN T-FORCE CLINICAL TRIAL

SAN DIEGO, Oct. 2, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a clinical trial of NBI-98854, a proprietary small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, in both children and adolescents with Tourette syndrome.

The T-Force study is an open-label, multi-dose, two-week study of 36 subjects with Tourette syndrome. Children and adolescents will receive once-daily dosing of NBI-98854 during a two-week treatment period to assess both the safety and tolerability of NBI-98854 in Tourette patients. Additionally, the Yale Global Tic Severity Scale and the Premonitory Urge for Tics Scale will be employed during the study to assess the impact of NBI-98854 on the patients' Tourette symptoms. Data readout from this study is expected in 2015.

"Advancing NBI-98854 into clinical evaluation of Tourette syndrome represents another significant achievement for our VMAT2 franchise," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "An important aspect of this initial Tourette syndrome trial is that we are exploring NBI-98854 in children age six to eleven, the target age range for therapy."

T-Force Study Design

The T-Force study is an open-label, multiple ascending dose, pharmacokinetic and pharmacodynamic, study to evaluate the safety, tolerability and exposure-response of NBI-98854 in children and adolescents with Tourette syndrome. A total of 36 patients will be evaluated over 14 days of once-daily dosing followed by 7 days off-drug at approximately 10 study centers in the United States. The study will be divided into two dosing groups consisting of children (ages 6-11) and adolescents (ages 12-18), and each age group will be further divided into three dosing cohorts of six patients each. After completing the initial two weeks of dosing with the first adolescent cohort, an independent review of both safety and pharmacokinetic results will occur prior to escalating the dose level for the second cohort of adolescents. In parallel, while initiating the second cohort of adolescents, the first cohort of children (ages 6-11) will also be administered NBI-98854 for a two-week period. Subsequent dose escalations for children and adolescents will be based, in part, on the pharmacokinetic and safety data from the previous cohort in each age group. Additionally, the patient's Tourette symptoms will be 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.
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Source: press release, 10/02/14. http://phx.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=...

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A Phase 1b, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
Estimated Enrollment: 36
Study Start Date: September 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02256475?term=NBI-98854&rank=7

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Valbenazine (NBI-98854) Tourette SyndromeNeurologyTourette SyndromeVMAT2 inhibitorVMAT2

Mechanism of action: Valbenazine (NBI-98854) is a potent, highly selective, VMAT2 inhibitor that is effective in regulating the levels of dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines.

Phase of Development: Ib

Event Type: Data: Phase Ib trial results

Dates: 2015-11-01 - 2015-12-31

Results:

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Neurocrine Announces Successful Completion of Phase Ib T-Force Study of VMAT2 Inhibitor NBI-98854 in Adolescents and Children with Tourette Syndrome
Once-Daily Valbenazine was Safe and Well Tolerated with a 31% Reduction from Baseline in Tourette Symptoms after Two Weeks of Treatment
Phase II Study in Children and Adolescents Planned To Start in First Half of 2016
SAN DIEGO, Dec. 16, 2015 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: 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."
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Source: press release, 12/16/15. http://phx.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=...

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