Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has completed the dosing and preliminary assessment of the initial cohort of Tardive Dyskinesia patients using its proprietary Vesicular Monoamine Transporter 2 inhibitor (VMAT2), NBI-98854. Based on this data, the Company is initiating the Investigational New Drug (IND) application process with the U.S. Food and Drug Administration (FDA).
"We are very pleased with these preliminary results from our VMAT2 Phase IIa study," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences. "Over the twelve days of treatment with our VMAT2 inhibitor, subjects showed a marked improvement in abnormal hyperkinetic movements. The drug was generally well tolerated and showed the desired pharmacokinetic profile previously demonstrated in two Phase I studies."
The open-label Phase IIa study was designed to assess efficacy, safety and tolerability of NBI-98854 in up to ten schizophrenia patients who have moderate to severe Tardive Dyskinesia over a twelve-day period. The impact on the dyskinesia was assessed utilizing the Abnormal Involuntary Movement Scale (AIMS). The dosing regimen consisted of three, four-day periods of NBI-98854 at increasing doses of 12.5mg, 25mg and 50mg administered once daily. After discontinuation of NBI-98854, a seven-day washout period was followed by a final assessment. The study inclusion criteria included a baseline total score of at least nine on the first seven components of the AIMS, with at least two body regions receiving scores of moderate (3) or severe (4). For this cohort of six subjects, the mean baseline score was 14.3 (AIMS total items 1-7, possible total score of 28).
After the twelve days of dosing in six subjects, the mean AIMS score decreased to 8.4, a reduction of 41.3%. Reduction in abnormal involuntary movements was shown across multiple assessment points. After the seven-day washout period most patients' AIMS scores returned to their baseline levels. The adverse events reported during administration of study drug were transient and mild or moderate including one subject with dizziness and one with restlessness. One subject became anxious and agitated seven days after stopping the study medication due to return of baseline-intensity dyskinesia.
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