Neurocrine's Ingrezza Meets Primary Goal In Phase 3 Study In Patients With Involuntary Muscle Movement

Neurocrine Biosciences Inc NBIX revealed topline data from its Phase 3 KINECT-HD study evaluating Ingrezza (valbenazine) for chorea associated with Huntington's disease (HD). 

• The selective vesicular monoamine transporter 2 (VMAT2) inhibitor is being investigated as a once-daily treatment in adult patients.
• Chorea is a movement disorder that causes involuntary, irregular, unpredictable muscle movements. 
• The study met the primary endpoint of reduction in the severity of chorea, the cardinal motor feature in Huntington's disease.
• Treatment with valbenazine resulted in a placebo-adjusted mean reduction in the chorea score of 3.2 units, indicating a highly statistically significant improvement in chorea. 
• The treatment-emergent adverse events observed in this trial were consistent with the known safety profile of valbenazine. 
• No suicidal behavior or worsening of suicidal ideation was observed in the valbenazine-treated subjects in this study. 
• Data from the Phase 3 KINECT-HD study will be presented at a medical conference in 2022.
• The Company will review the complete data and prepare a supplemental marketing application for submission to the FDA in 2022. 
• Neurocrine will continue dosing in the KINECT-HD2 study, evaluating the long-term safety and tolerability of valbenazine in this same patient population.
• HD is a hereditary progressive, fatal neurodegenerative disorder in which neurons within the brain break down, resulting in motor, cognitive and psychiatric symptoms.
• Related Link: Neurocrine Pens $2.6B Pact With Sosei Heptares For Neuro Targets. 
• Price Action: NBIX shares closed 3.04% at $84.75 during after-hours trading on Tuesday.