Full Press Release Details
SAN DIEGO , Nov. 4, 2015 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX ), a biotechnology company focused on neurological and endocrine related disorders, announced today that the Company's Investigational New Drug (IND) application, filed with the U.S. Food and Drug Administration, for NBI-640756 for patients with essential tremor is now active. NBI-640756 was discovered in the Neurocrine laboratories and the Company has initiated a sequential dose-escalation Phase I safety and pharmacokinetics study exploring NBI-640756 in healthy volunteers, with top-line data expected the first-half of next year.
"Neurocrine's research team has added another facet to our growing franchise in movement disorders by discovering a novel compound that shows great promise in preclinical models of essential tremor," said Kevin C. Gorman , President and Chief Executive Officer of Neurocrine Biosciences. "A successful readout from this initial Phase I study will lead to the initiation of a multiple ascending dose study of NBI-640756 next year."
Phase I Study Design
This Phase I study is a single site, randomized, double-blind, placebo-controlled, sequential dose-escalation, pharmacokinetic study assessing the safety and tolerability of a single dose of NBI-640756 in up to 32 healthy volunteers. The study will be conducted in multiple sequential cohorts of eight subjects per cohort.
About Essential Tremor
Essential tremor is one of the most common neurological disorders in adults, impacting an estimated 10 million Americans (International Essential Tremor Foundation). The disorder is characterized by involuntary, rhythmic, oscillatory movements that most often affect the upper limbs. As the disease progresses, tremor severity often increases and spreads to other parts of the body. Essential tremor has a significant impact on the activities of daily living often resulting in functional disability as the disease progresses and is associated with a high comorbidity rate of social phobia, depression and anxiety. Current pharmacological therapies utilized in the treatment of essential tremor include propranolol and primidone. Deep brain stimulation, an invasive procedure involving the implantation of electrodes within certain areas of the brain, is sometimes utilized for severe essential tremor.
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 NBI-98854, 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 .
SOURCE Neurocrine Biosciences, Inc.