SAN DIEGO, Dec. 21 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced their highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, NBI-98854, will be advanced in clinical development.
The first trial in human subjects, NBI-98854-0801, was a single ascending dose trial in healthy male volunteers conducted in Canada under an approved Clinical Trial Application (CTA) with Health Canada. Preliminary data have now been reviewed; NBI-98854 was generally safe and well tolerated. There were no Serious Adverse Events, clinically significant drug-related laboratory abnormalities or clinically significant ECG findings. More critically, the characteristics of the compound met the pre-specified pharmacokinetic requirements: dose proportionality, low maximum concentration (Cmax) with adequate area-under-curve (AUC) for drug exposure, low variability, and a half-life which supports once per day dosing.
"The results of this first clinical trial in our VMAT2 inhibitor are exactly what we were seeking," said Chris O'Brien, Chief Medical Officer of Neurocrine Biosciences. "We will now move NBI-98854 into a multiple repeated dose Phase 1 study and begin preparation for Phase 2 proof of concept trial to be initiated later in 2010."
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 is effective in regulating the levels of 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.
The next step for this VMAT2 development program is to complete a multiple, repeated dose Phase 1 study in healthy male volunteers after approval of the Canadian CTA submission. Once complete, 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, benign prostatic hyperplasia (BPH), irritable bowel syndrome (IBS) 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, 2008 and reports of 10-Q for the quarter ended September 30, 2009. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.
|SOURCE Neurocrine Biosciences, Inc.|
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