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Neurocrine Biosciences’ (NBIX) VMAT2 Program to Move Into Phase II Clinical Trials

Yesterday, Neurocrine Biosciences Inc., a biopharmaceutical company that specializes in neurological and endocrine diseases and disorders, announced that it passed its second Phase I clinical trial of its compound NBI-98854, a drug that inhibits VMAT2. The successful testing on healthy volunteers means Neurocrine can proceed with Phase II testing.

VMAT2 is a protein found in the human brain that is responsible for moving monoamines (chemicals like dopamine, norepinephrine, serotonin, and histamine) to nerve cells. NBI-98854 is a new kind of VMAT2 inhibitor that measures dopamine release to nerves, while having a minimal effect on the other kinds of monoamines in the brain, reducing negative side effects from the medication.

With the successful completion of the Phase IIa study, Neurocrine plans to file with the FDA an Investigational New Drug application to move on to Phase IIb studies in patients with the disorder Tardive Dyskinesia. NBI-98854 may prove helpful in treating other neurological disorders as well, including schizophrenia and Tourette’s syndrome.

“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.”

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