Neurocrine Biosciences Announces the Initiation of Second VMAT2 Phase I Clinical Trial
SAN DIEGO, April 13 /PRNewswire-FirstCall/ — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has received approval from Health Canada to commence its second Phase I clinical trial of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854.
“We are looking forward to starting our Phase I multiple repeated dose study of VMAT2 this month,” said Christopher F. O’Brien, Chief Medical Officer of Neurocrine Biosciences. “Our VMAT2 inhibitor was well tolerated and showed us the desired pharmacokinetic profile in the first Phase I study. We are now assessing PK and safety profiles after repeated dosing in healthy volunteers. These data, if favorable, will facilitate the initiation of a Phase II proof-of-concept study later this year.”
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) among nerve cells. 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 the active drug to minimize side effects associated with excessive dopamine depletion.
Upon successful completion of this study, Neurocrine will approach the FDA regarding the filing of an Investigational New Drug application in the United States with the express purpose of initiating the proof-of-concept study in patients with Tardive Dyskinesia late in 2010. In addition, NBI-98854 may well be useful in other disorders, such as Huntington’s chorea, schizophrenia, Tourette’s syndrome, and Tardive Dystonia.
Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including endometriosis, anxiety, depression, pain, diabetes, irritable bowel syndrome and other neurological and endocrine related diseases and disorders. 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 the Company’s VMAT2 program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company’s VMAT2 program include, but are not limited to; risk that NBI-98854 will not proceed to later stage clinical trials and risk that the Company’s clinical trials will fail to demonstrate that NBI-98854 is safe and effective. With respect to its pipeline overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company’s dependence on contract manufacturers for clinical drug supply; risks associated with the Company’s dependence on corporate partners for development, commercial manufacturing and marketing and sales activities for the Company’s partnered programs; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company’s products; and the other risks described in the Company’s report on Form 10-K for the year ended December 31, 2009. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.