SAN DIEGO, CA, USA I October 20, 2014 I Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Monoamine Transporter 2 compound, NBI-98854. The design of the Kinect 3 Study is a randomized, parallel-group, double-blind, placebo-controlled trial of approximately 240 subjects with moderate to severe tardive dyskinesia and an underlying diagnosis of mood disorder, schizophrenia or schizoaffective disorder. The initial six weeks of treatment consists of an efficacy and safety assessment of 80mg and 40mg once-daily NBI-98854 against placebo. This is followed by an additional 46 weeks of long-term safety assessment where all subjects are randomized in a blinded fashion to either 80mg or 40mg once-daily NBI-98854. Topline efficacy data is expected in the second half of 2015.
“The Kinect 3 Study for NBI-98854 is designed to round out our placebo-controlled efficacy dataset for the tardive dyskinesia NDA,” said Christopher F. O’Brien, Chief Medical Officer of Neurocrine Biosciences. “This study contributes to the most comprehensive registration effort of a potential therapeutic agent for tardive dyskinesia. We anticipate filing the NDA with the FDA in the second half of 2016.”
Kinect 3 Study Design
The Kinect 3 study is a randomized, parallel-group, double-blind, placebo-controlled, Phase III clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder). The primary endpoint in the Kinect 3 study will be the mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded central raters. The Kinect 3 study will include approximately 240 subjects randomized to either placebo, once daily 40mg of NBI-98854 or once daily 80mg of NBI-98854 for six weeks. Subsequent to the completion of the six week placebo-controlled dosing, all subjects will continue on once daily 40mg or once daily 80mg of NBI-98854 through Week 48.
Top-line efficacy data from the initial six weeks of placebo-controlled dosing is expected in the second half of 2015.
The Kinect 3 study, along with the previous efficacy studies of NBI-98854, is designed to complete the placebo-controlled clinical efficacy evaluation of NBI-98854 in tardive dyskinesia. The Company also intends to conduct a separate one-year, open-label safety study of NBI-98854 to support the anticipated filing of a New Drug Application (NDA) in tardive dyskinesia during 2016.
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities: lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips, or involuntary movements of the limbs. These symptoms are rarely reversible and there are currently no approved treatments.
About NBI-98854
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.
In addition to this tardive dyskinesia study, the Company has recently initiated a clinical study assessing NBI-98854 in children and adolescents with Tourette syndrome.
The Company has two distinct Investigational New Drug Applications, tardive dyskinesia and Tourette syndrome, open with the Division of Psychiatry Products at the FDA.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders. The Company’s two lead late-stage clinical programs are elagolix, a gonadotropin-releasing hormone antagonist for women’s health that is partnered with AbbVie Inc., and a wholly owned vesicular monoamine transporter 2 inhibitor for the treatment of movement disorders. Neurocrine intends to maintain certain commercial rights to its VMAT2 inhibitor for evolution into a fully-integrated pharmaceutical company. Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the internet at http://www.neurocrine.com.
SOURCE: Neurocrine
Post Views: 32
SAN DIEGO, CA, USA I October 20, 2014 I Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Monoamine Transporter 2 compound, NBI-98854. The design of the Kinect 3 Study is a randomized, parallel-group, double-blind, placebo-controlled trial of approximately 240 subjects with moderate to severe tardive dyskinesia and an underlying diagnosis of mood disorder, schizophrenia or schizoaffective disorder. The initial six weeks of treatment consists of an efficacy and safety assessment of 80mg and 40mg once-daily NBI-98854 against placebo. This is followed by an additional 46 weeks of long-term safety assessment where all subjects are randomized in a blinded fashion to either 80mg or 40mg once-daily NBI-98854. Topline efficacy data is expected in the second half of 2015.
“The Kinect 3 Study for NBI-98854 is designed to round out our placebo-controlled efficacy dataset for the tardive dyskinesia NDA,” said Christopher F. O’Brien, Chief Medical Officer of Neurocrine Biosciences. “This study contributes to the most comprehensive registration effort of a potential therapeutic agent for tardive dyskinesia. We anticipate filing the NDA with the FDA in the second half of 2016.”
Kinect 3 Study Design
The Kinect 3 study is a randomized, parallel-group, double-blind, placebo-controlled, Phase III clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder). The primary endpoint in the Kinect 3 study will be the mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded central raters. The Kinect 3 study will include approximately 240 subjects randomized to either placebo, once daily 40mg of NBI-98854 or once daily 80mg of NBI-98854 for six weeks. Subsequent to the completion of the six week placebo-controlled dosing, all subjects will continue on once daily 40mg or once daily 80mg of NBI-98854 through Week 48.
Top-line efficacy data from the initial six weeks of placebo-controlled dosing is expected in the second half of 2015.
The Kinect 3 study, along with the previous efficacy studies of NBI-98854, is designed to complete the placebo-controlled clinical efficacy evaluation of NBI-98854 in tardive dyskinesia. The Company also intends to conduct a separate one-year, open-label safety study of NBI-98854 to support the anticipated filing of a New Drug Application (NDA) in tardive dyskinesia during 2016.
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities: lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips, or involuntary movements of the limbs. These symptoms are rarely reversible and there are currently no approved treatments.
About NBI-98854
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.
In addition to this tardive dyskinesia study, the Company has recently initiated a clinical study assessing NBI-98854 in children and adolescents with Tourette syndrome.
The Company has two distinct Investigational New Drug Applications, tardive dyskinesia and Tourette syndrome, open with the Division of Psychiatry Products at the FDA.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders. The Company’s two lead late-stage clinical programs are elagolix, a gonadotropin-releasing hormone antagonist for women’s health that is partnered with AbbVie Inc., and a wholly owned vesicular monoamine transporter 2 inhibitor for the treatment of movement disorders. Neurocrine intends to maintain certain commercial rights to its VMAT2 inhibitor for evolution into a fully-integrated pharmaceutical company. Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the internet at http://www.neurocrine.com.
SOURCE: Neurocrine
Post Views: 32
