12-Week T-Force GOLD Study to Assess the Safety, Tolerability, Efficacy and Optimal Dose of INGREZZA in Pediatric Patients
SAN DIEGO, CA, USA I October 25, 2017 I Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a Phase IIb clinical trial, T-Force GOLD, for INGREZZA® (valbenazine), a novel selective vesicular monoamine transporter 2 (VMAT2) inhibitor, in children and adolescents with Tourette syndrome. Tourette syndrome is a neurological disorder that becomes evident in early childhood or adolescence and is characterized by motor and vocal tics.
“We are committed to continuing studies of INGREZZA in patients with neurological disorders including pediatric patients with Tourette syndrome,” said Christopher F. O’Brien, Chief Medical Officer of Neurocrine Biosciences. “We have gained valuable insights from our previous studies of INGREZZA in patients with Tourette syndrome and look forward to continuing to advance this program to further assess INGREZZA as a potential treatment option for pediatric Tourette patients.”
INGREZZA capsules are marketed in the United States for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face.
T-Force GOLD Study Design
The T-Force GOLD study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase IIb study to evaluate the safety, tolerability, efficacy and optimal dose of once-daily INGREZZA in up to 120 pediatric patients with moderate to severe Tourette syndrome. Patients will receive either once-daily dosing of INGREZZA or placebo using a 1:1 randomization over 12 weeks of dosing followed by two weeks off-drug. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of week 12. Tourette symptoms will also be evaluated via the Premonitory Urge for Tics Scale as well as Clinical Global Impression Scales. Top-line data from this study is expected in late 2018.
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 stereotyped 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.
About INGREZZA® (valbenazine) capsules
INGREZZA, a selective 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 trunk, extremities and/or face.
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. INGREZZA is currently in clinical development for the treatment of Tourette syndrome.
About Neurocrine Biosciences
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company markets INGREZZA® (valbenazine) capsules in the United States for the treatment of adults with tardive dyskinesia. INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia. The Company’s three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women’s health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson’s patients; and INGREZZA, a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette syndrome.
SOURCE: Neurocrine Biosciences
Post Views: 112
12-Week T-Force GOLD Study to Assess the Safety, Tolerability, Efficacy and Optimal Dose of INGREZZA in Pediatric Patients
SAN DIEGO, CA, USA I October 25, 2017 I Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a Phase IIb clinical trial, T-Force GOLD, for INGREZZA® (valbenazine), a novel selective vesicular monoamine transporter 2 (VMAT2) inhibitor, in children and adolescents with Tourette syndrome. Tourette syndrome is a neurological disorder that becomes evident in early childhood or adolescence and is characterized by motor and vocal tics.
“We are committed to continuing studies of INGREZZA in patients with neurological disorders including pediatric patients with Tourette syndrome,” said Christopher F. O’Brien, Chief Medical Officer of Neurocrine Biosciences. “We have gained valuable insights from our previous studies of INGREZZA in patients with Tourette syndrome and look forward to continuing to advance this program to further assess INGREZZA as a potential treatment option for pediatric Tourette patients.”
INGREZZA capsules are marketed in the United States for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face.
T-Force GOLD Study Design
The T-Force GOLD study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase IIb study to evaluate the safety, tolerability, efficacy and optimal dose of once-daily INGREZZA in up to 120 pediatric patients with moderate to severe Tourette syndrome. Patients will receive either once-daily dosing of INGREZZA or placebo using a 1:1 randomization over 12 weeks of dosing followed by two weeks off-drug. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of week 12. Tourette symptoms will also be evaluated via the Premonitory Urge for Tics Scale as well as Clinical Global Impression Scales. Top-line data from this study is expected in late 2018.
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 stereotyped 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.
About INGREZZA® (valbenazine) capsules
INGREZZA, a selective 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 trunk, extremities and/or face.
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. INGREZZA is currently in clinical development for the treatment of Tourette syndrome.
About Neurocrine Biosciences
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company markets INGREZZA® (valbenazine) capsules in the United States for the treatment of adults with tardive dyskinesia. INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia. The Company’s three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women’s health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson’s patients; and INGREZZA, a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette syndrome.
SOURCE: Neurocrine Biosciences
Post Views: 112
