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."