#USA #San Diego #Neurocrine Biosciences #INGREZZA #Tardive Dyskinesia

Neurocrine Biosciences Unveils KINECT-PRO™ Findings

Neurocrine Biosciences, a prominent biopharmaceutical company, has announced significant findings from its KINECT-PRO™ Phase 4 study, showcasing how INGREZZA® (valbenazine) capsules have improved the quality of life and daily functioning for individuals living with tardive dyskinesia (TD). This groundbreaking study is unique as it provides clinical trial data demonstrating these improvements based on multiple validated patient-reported outcomes (PROs).

Overview of KINECT-PRO™ Study

On August 12, 2026, Neurocrine highlighted results that revealed substantial and sustainable enhancements in patient-reported metrics alongside improved clinician-rated movement severity for those diagnosed with TD. The study's participant demographics encompassed patients across various psychiatric conditions, suggesting that the therapeutic effects of INGREZZA extend beyond specific diagnoses and movement severities. The publication of these findings in the journal CNS Spectrums adds credibility to the results.

KINECT-PRO is distinguished as the first study to examine how a vesicular monoamine transporter 2 (VMAT2) inhibitor impacts quality of life through validated evaluation scales, most notably the Tardive Dyskinesia Impact Scale (TDIS™), developed meticulously by Neurocrine in collaboration with top neurologists and psychiatrists. This scale captures a patient's perspective on the social, physical, and emotional ramifications of TD.

Meaningful Outcomes

The results of the KINECT-PRO study revealed that around 58% of participants achieved a stage of symptomatic remission from TD by week 24, characterized by minimal or no movement severity in assessed body areas. The findings indicate that even those with mild TD movements can significantly benefit from INGREZZA treatment, enhancing their overall functionality and quality of life.

Dr. Sanjay Keswani, Chief Medical Officer at Neurocrine, emphasized the necessity of evaluating treatment impacts on quality of life and functioning. He remarked, "These findings reinforce the extensive evidence showing the meaningful benefits of INGREZZA on movement severity, quality of life, and overall patient functionality."

Evaluating Quality of Life and Functionality

The core focus of the KINECT-PRO study was measuring the improvements in quality of life and day-to-day function using a set of validated patient-reported measures over a 24-week treatment period. The primary endpoints included:

• - TDIS: Assesses the physical, social, and emotional impact of TD.
• - EuroQoL Visual Analogue Scale (EQ-VAS): Measures patient self-rated health status.
• - Sheehan Disability Scale (SDS): Addresses functional impairments in work, social life, and family activities.

Substantial improvements were observed in the participants, with mean scores of TD impact and clinician-rated severity indicating progress well above the established minimal clinically important differences. Improvements were also consistent across varying levels of baseline movement severity and psychiatric diagnosis.

A Comprehensive Treatment Insight

The trial included around 59 patients who received INGREZZA (at dosages of 40 mg, 60 mg, or 80 mg) once daily for a duration of 24 weeks. With a completed visit rate of 88%, the study assured that the group's baseline characteristics were similar to those involved in prior KINECT studies, lending additional merit to the findings.

Approximately 46% of the participants had a diagnosis of schizophrenia or schizoaffective disorder, while around 54% were diagnosed with major depressive disorder or bipolar disorder. Notably, all participant subgroups exhibited considerable benefits, corroborating the medication's efficacy.

Conclusion

The KINECT-PRO study positions INGREZZA as a pivotal treatment for patients grappling with tardive dyskinesia, establishing a new gold standard for addressing quality of life alongside movement severity. As Neurocrine Biosciences continues its endeavor to alleviate patient suffering, the study not only enhances understanding of tardive dyskinesia but also represents a critical step forward in therapeutic advancements.

Patients with TD can take comfort in the promising implications of these findings, which reinforce the potential for meaningful treatment outcomes with INGREZZA. The study underscores that improved daily functioning is obtainable, providing hope for those affected by this challenging movement disorder.