Neurocrine Biosciences Announces Topline Data from Phase IIb T-Force GOLD Study Demonstrating Valbenazine Did Not Meet Primary Endpoint in Pediatric Patients with Tourette Syndrome
SAN DIEGO, Dec. 12, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced topline data from the Phase IIb T-Force GOLD study demonstrating that valbenazine did not meet the primary endpoint as assessed by the Yale Global Tic Severity Scale (YGTSS) in children and adolescents with moderate to severe Tourette syndrome. The types of treatment emergent adverse events observed in this trial were consistent with those seen in other valbenazine studies.
"We are very disappointed with the topline data from the T-Force GOLD study given that children and adolescents with Tourette syndrome need better treatment options. This study was well-conducted with a placebo response as expected, but the treatment effect of valbenazine was lower than we had anticipated," said Kevin Gorman, Ph.D., Chief Executive Officer at Neurocrine Biosciences. "We would like to thank the patients, caregivers and investigators for their participation in this study. We will further analyze the data to determine the next steps for valbenazine in Tourette syndrome."
Neurocrine Biosciences continues to focus on developing treatments for neurological and endocrine related disorders. The company discovered, developed and markets INGREZZA®(valbenazine) capsules, the first U.S. Food and Drug Administration(FDA) approved product indicated for the treatment of adults with tardive dyskinesia, an involuntary movement disorder. In addition, as part of a collaboration with AbbVie, ORILISSA™ (elagolix) was approved in 2018 by the FDA for the treatment of endometriosis. Other clinical development programs include opicapone for Parkinson's disease patients, elagolix for uterine fibroids with AbbVie and NBI-74788 for the treatment of congenital adrenal hyperplasia (CAH).
Conference Call and Webcast Today at 8:30 a.m. Eastern Time
Neurocrine will hold a live conference call and webcast today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Participants can access the live conference call by dialing 877-830-2589 (US) or 785-424-1052 (International) using the conference ID: NBIX. The call can also be accessed via the webcast through the Company's website at www.neurocrine.com.
T-Force GOLD Study Design
The T-Force GOLD study was a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase IIb study to evaluate the safety, tolerability and efficacy of once-daily valbenazine capsules in 127 pediatric patients with moderate to severe Tourette syndrome. Patients received either once-daily dosing of valbenazine or placebo using a 1:1 randomization over 12 weeks of dosing followed by two weeks off-drug. The first six weeks of the trial was a dose optimization phase, with dose escalations allowed at week two or week four. The primary endpoint of T-Force GOLD was the change from baseline of the YGTSS Total Tic Score at week 12. The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity and interference.
About Tourette Syndrome
Tourette syndrome is a neurological disorder that consists of rapid, non-rhythmic stereotyped motor and vocal tics. Motor tics are typically characterized by facial grimacing, head jerks, extremity movements and other dystonic movements. Vocal tics typically include grunting, throat clearing, and repeating words and phrases. The average age of onset for Tourette syndrome is six years, with symptoms reaching their peak severity at approximately age ten. Tourette syndrome is more commonly diagnosed in males than females and may be associated with attention deficit hyperactivity disorder and obsessive-compulsive disorder as part of a broader spectrum diagnosis.
About INGREZZA® (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso, and/or other body parts.
INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed in Neurocrine's laboratories, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.
About Neurocrine Biosciences, Inc.
Neurocrine Biosciences, a San Diego based biopharmaceutical company, is focused on developing treatments for neurological and endocrine related disorders. The company discovered, developed and markets INGREZZA® (valbenazine) capsules, the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, an involuntary movement disorder. Discovered and developed through Phase II clinical trials by Neurocrine, ORILISSA™ (elagolix), the first FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain in over a decade, is marketed by AbbVieas part of a collaboration to develop and commercialize elagolix for women's health. Neurocrine's clinical development programs include opicapone as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in Parkinson's disease patients, elagolix for uterine fibroids with AbbVie, valbenazine for the treatment of Tourette syndrome, and NBI-74788 for the treatment of congenital adrenal hyperplasia (CAH). For more information and the latest updates from Neurocrine Biosciences, please visit www.neurocrine.com.
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