Neurocrine Biosciences Shares KINECT-PRO™ Study Outcomes for INGREZZA® Showing Major Functional and Quality of Life Improvements in Tardive Dyskinesia

Neurocrine Biosciences, Inc., a leading biopharmaceutical company, has released promising results from their Phase 4 KINECT-PRO™ study, assessing the impact of INGREZZA® (valbenazine) capsules on patients suffering from tardive dyskinesia (TD). This study is notable for its focus on patient-reported outcomes, a crucial aspect given that TD significantly affects various facets of patients' lives, including daily activities, work, and social interactions. The data was gathered using multiple validated scales, including the Tardive Dyskinesia Impact Scale (TDIS), designed to capture physical, social, and emotional impacts of the disorder.

The KINECT-PRO study involved 59 participants who were administered different doses of INGREZZA (40 mg, 60 mg, or 80 mg) over a 24-week period. Notably, 52 patients completed the study. Participants were categorized based on TD severity—mild or moderate/severe—and underlying psychiatric conditions, such as schizophrenia, schizoaffective disorder, bipolar disorder, or major depression. This broad inclusion ensured that the study reflects a real-world clinical scenario.

The primary aim of the research was to evaluate improvements in patient-reported physical, social, and emotional impacts of TD during the treatment with INGREZZA. Evaluations were conducted at several intervals (Weeks 4, 8, 16, and 24) using three scales: the Tardive Dyskinesia Impact Scale (TDIS), the Sheehan Disability Scale (SDS), and the EQ Visual Analogue Scale (EQ-VAS). Furthermore, the study sought to examine changes in TD severity through both patient and clinician assessments, using tools such as the Abnormal Involuntary Movement Scale (AIMS), the Patient Global Impression of Change–TD (PGI-C), and the Clinical Global Impression of Severity–TD (CGI-TD-S).

Findings from the KINECT-PRO study demonstrated significant and lasting improvements across all patient-reported measures, with notable progress observable as early as four weeks into treatment at the lowest dosage. These improvements were consistent regardless of the initial severity of TD or the underlying psychiatric conditions of the patients. Additionally, the safety profile of INGREZZA was consistent with previous studies, with no new safety concerns identified.

INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor that is already approved by the U.S. Food and Drug Administration for treating adults with tardive dyskinesia and chorea associated with Huntington's disease. Its unique mechanism targets VMAT2 to inhibit dopamine release, which is believed to mitigate the uncontrollable movements characteristic of TD.

The KINECT-PRO study not only underscores the efficacy of INGREZZA in reducing the involuntary movements associated with TD but also highlights its potential to improve quality of life for patients by addressing the broader socio-emotional impacts of the disorder. This is particularly significant as TD is often a side effect of long-term use of antipsychotic medications used to treat various mental health disorders. INGREZZA offers a therapeutic dosage from day one without the need for titration and can be integrated with other stable mental health regimens.

In summary, the KINECT-PRO study presents compelling evidence of INGREZZA's benefits for patients with tardive dyskinesia, reinforcing its role as a vital treatment option in managing this challenging condition. The results will be further disseminated at upcoming scientific conferences, providing an opportunity for the medical community to engage with this important data.