Stock of Neurocrine Biosciences gained almost 50% for the last week on Phase I clinical trial of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854.
This security should rest for a some time; short sell – period.
Neurocrine Biosciences Announces That VMAT2 Program Will Move Into Phase II Clinical Trials
PR Newswire “Press Releases US – English “
SAN DIEGO , Oct. 18 /PRNewswire-FirstCall/ — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has successfully completed a second Phase I clinical trial of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. The positive results of this Phase I study of repeated dosing in healthy volunteers allows the VMAT2 program to initiate Phase II studies.
“Our VMAT2 inhibitor was well tolerated and again showed us the desired pharmacokinetic and safety profiles after repeated dosing in healthy volunteers,” said Christopher F. O’Brien , Chief Medical Officer of Neurocrine Biosciences . “Based on the data set from our Phase I studies, we plan to initiate a Phase IIa dose exploration study in Tardive Dyskinesia patients by year end.”
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 presynaptic 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 initial Phase IIa study, Neurocrine plans to approach the FDA regarding the filing of an Investigational New Drug application in the United States with the express purpose of initiating larger Phase IIb studies in patients with Tardive Dyskinesia. 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.