Neurocrine Biosciences (NBIX) Presents INGREZZA Data

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present data demonstrating sustained improvements with long-term INGREZZA® (valbenazine) capsules treatment in adults with tardive dyskinesia (TD) at the Psych Congress 2022 scientific meeting being held September 17-20.

Neurocrine Biosciences, the leading neuroscience-focused company in the treatment of TD, will present findings from a post hoc analysis of the 48-week, open-label KINECT 4 study of INGREZZA evaluating treatment response patterns (Poster #75; Sustained Treatment Response with Long-Term Valbenazine in Patients with Tardive Dyskinesia). The analysis, which included treatment completers of KINECT 4 (n=103), found that the proportion of patients meeting rigorous response criteria increased over time:

• The proportion of participants who reached a ≥50 percent Abnormal Involuntary Movement Scale (AIMS) improvement from baseline increased from week 8 to week 48 (39 percent [n=40] to 86 percent [n=89] of participants, respectively).
• Of the 40 participants (39 percent) with AIMS ≥50 percent response at week 8, 95 percent (38 participants) also met this threshold at week 48, demonstrating a sustained response.
• An increase in proportion of participants that met the rigorous 70 percent or more AIMS improvement from baseline increased from week 8 to week 48 (17 percent [n=18] to 52 percent [n=54] of participants, respectively).
• Rates of participants meeting the defined global response threshold (rating of "much improved" or "very much improved") increased from week 8 to week 48, from 50 percent to 92 percent for Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and 53 percent to 88 percent for Patient Global Impression of Change (PGIC), respectively.

"TD can disrupt many aspects of day-to-day life, and adequate assessment, diagnosis, and continued management of symptoms are of key importance," said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. "These data demonstrate that a vast majority of participants taking INGREZZA obtained substantial and sustained TD improvement throughout the study, and the proportion of patients achieving symptom relief increased with continued treatment over time."

The most common treatment-emergent adverse events (TEAE) reported in KINECT 4 (≥5 percent of all INGREZZA-treated patients after week 4) were urinary tract infection (8.5 percent) and headache (5.2 percent).

Additional presentations include:

• Healthcare Provider Perspective of Benztropine Use in Drug-Induced Movement Disorders, Including Tardive Dyskinesia, a 2021-2022 Real-World Survey (Poster #46)
• Treatment Success and Psychiatric Stability in Adults with Tardive Dyskinesia: Post Hoc Analyses of Two Long-Term Valbenazine Studies (Poster #7)
• Anticholinergics Should Not Be Used to Treat Tardive Dyskinesia: Insights from an Expert Panel of Psychiatry and Neurology Healthcare Professionals (Poster #36)

The full abstracts being presented by Neurocrine Biosciences at the Psych Congress 2022 can be accessed by registering for the meeting (national.psychcongress.com/rates).

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