SAN DIEGO, March 2, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that on April 20, 2016, data from the Phase III Kinect 3 study of valbenazine (NBI-98854) for tardive dyskinesia will be presented during a plenary session at the American Academy of Neurology Annual Meeting in Vancouver. In addition, data from the Kinect 1 and Kinect 2 clinical trials of valbenazine will also be reviewed in two platform presentations on April 19, 2016 at this important meeting. The AAN Annual Meeting is the largest international conference of neurologists, bringing together over 10,000 clinicians and scientists to address current topics in neurology.
The April 20th plenary session, "KINECT 3: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Valbenazine (NBI-98854) for Tardive Dyskinesia," will be led by Dr. Robert Hauser from the University of South Florida Parkinson's Disease and Movement Disorders Center. Two platform presentations, "Open-Label Extension of KINECT: A Phase 2 Study of Valbenazine (NBI-98854) for Tardive Dyskinesia" and "A Phase 2 Study of Valbenazine (NBI-98854) for Treatment of Tardive Dyskinesia: KINECT 2" will occur the morning of April 19, 2016. All three presentations will describe the methodology of each clinical trial, safety and efficacy results, and statistical findings along with key clinical observations.
"We are very pleased to have our Kinect 3 data accepted for presentation and discussion during a plenary session at the 68th Annual Meeting of the American Academy of Neurology in Vancouver in April. This, coupled with two additional platform presentations, allows us to share the breadth and depth of our late-stage tardive dyskinesia clinical efforts with the worldwide experts in movement disorders," said Chris O'Brien, M.D., Chief Medical Officer at Neurocrine. "These presentations describe the conduct and outcomes of three rigorous, well-controlled clinical trials in tardive dyskinesia, representing a significant advance for this therapeutic area. Our medical affairs team will also be present at this key meeting next month to discuss this important data."
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. Valbenazine (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. Valbenazine 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 FDA for valbenazine in the treatment of tardive dyskinesia and expects to file a New Drug Application for tardive dyskinesia in 2016. Valbenazine is also currently in Phase II development for Tourette syndrome.
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 valbenazine, a 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.
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 (valbenazine) development. Specifically, the risks and uncertainties the Company faces include risks that valbenazine development activities may not be completed on time or at all; risks that valbenazine development activities may be delayed for regulatory or other reasons, may fail to demonstrate that valbenazine is safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that valbenazine regulatory submissions may not occur or be submitted in a timely manner; risks that valbenazine may not obtain regulatory approval or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding valbenazine; risks that valbenazine may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with the Company's dependence on third parties for development and manufacturing activities related to valbenazine; risks that the Company will be unable to raise additional funding, if required, to complete development of valbenazine; risks and uncertainties relating to competitive products and technological changes that may limit demand for valbenazine; and other risks described in the Company's annual report on Form 10-K for the year ended December 31, 2015. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.