Neurocrine Announces Successful Completion of Phase Ib T-Force Study of VMAT2 Inhibitor NBI-98854 in Adolescents and Children with Tourette Syndrome
"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
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
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 at onset for Tourette syndrome is at age six, 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. There are approximately 400,000 people with Tourette syndrome in
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. NBI-98854, developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines, thereby reducing the likelihood of "off-target" side effects. NBI-98854 is designed to provide low, sustained, plasma and brain concentrations of active drug to minimize side effects associated with excessive monoamine depletion.
Modulation of neuronal dopamine levels in diseases such as tardive dyskinesia, Tourette syndrome, Huntington's chorea, schizophrenia, and tardive dystonia, which are characterized, in part, by a hyperdopaminergic state, should provide symptomatic benefits for patients with these diseases.
Neurocrine has received Breakthrough Therapy Designation from the
In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general, as well as risks and uncertainties associated with NBI-98854 development. Specifically, the risks and uncertainties the Company faces include risks that NBI-98854 development activities for either tardive dyskinesia or Tourette syndrome, or both, may not be completed on time or at all; risks that NBI-98854 development activities for either tardive dyskinesia or Tourette syndrome, or both, may be delayed for regulatory or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that NBI-98854 is safe and effective for either tardive dyskinesia or Tourette syndrome, or both,, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that NBI-98854 regulatory submissions may not occur or be submitted in a timely manner; risks that NBI-98854 may not obtain regulatory approval for either tardive dyskinesia or Tourette syndrome, or both, or that the
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