Abstract Details

Title Sustained Chorea Improvements with Long-term, Once-daily Valbenazine in Adults with Huntington’s Disease

Topic Movement Disorders

Presentation(s) S37 - Movement Disorders: Clinical Trials (2:36 PM-2:48 PM)

Poster/Presentation
Number 009

Background In the phase 3 KINECT®-HD (NCT04102579) study, valbenazine significantly improved chorea versus placebo. Concomitant antipsychotics were allowed in KINECT-HD2, which was designed to evaluate long-term safety and tolerability of valbenazine and its maintenance of effect on chorea.

Objective To present results from KINECT®-HD2 (NCT04400331), an open-label study of once-daily valbenazine for chorea in adults with Huntington's disease (HD).

Design/Methods KINECT-HD2 participants received once-daily valbenazine (starting dose: 40 mg; target maintenance dose: 80 mg) for ≤156 weeks with an optional 2-year extended-maintenance period. Safety outcomes include treatment-emergent adverse events (TEAEs), as reported at any study visit in the overall study population. Efficacy outcomes are reported through Week 104 and include the following: mean changes from baseline in Unified Huntington’s Disease Rating Scale Total Maximal Chorea (TMC) score; and response status (“much improved” or better) for Clinical Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C). TMC results are also presented for subgroups taking concomitant antipsychotics through Week 50. Outcomes are presented descriptively.

Results Among 154 participants receiving ≥1 dose of valbenazine, 150 (97.4%) reported ≥1 TEAE and 24 (15.6%) discontinued due to a TEAE, most commonly for fatigue (2.6%) and anxiety (2.6%). Common TEAEs were fall (42.9%), somnolence (25.3%), and fatigue (21.4%). Serious TEAEs were reported for 24 (15.6%) participants. Mean (±SEM) TMC improvements were observed by Week 2 with valbenazine 40 mg (-3.4±0.3 [n=146]) and sustained with ≤80 mg from Week 8 (-5.7±0.3 [n=139]) to Week 104 (-5.2±0.5 [n=87]). TMC improvements were similar through Week 50 for participants taking concomitant antipsychotics (-6.0±1.1 [n=20]) and for those with no concomitant antipsychotic use (-5.7±0.4 [n=84]).

Conclusions

KINECT-HD2 results indicate acceptable long-term safety/tolerability of once-daily valbenazine, along with rapid, sustained, and clinically meaningful chorea improvement. Outcomes with valbenazine in adults with HD chorea were unaffected by concomitant use of antipsychotic therapy.

Authors/Disclosures
Dietrich Haubenberger, MD, FAAN (Neurocrine Biosciences) PRESENTER	Dr. Haubenberger has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Dr. Haubenberger has stock in Neurocrine Biosciences. Dr. Haubenberger has a non-compensated relationship as a Member of the Board with American Society for Experimental Neurotherapeutics that is relevant to AAN interests or activities.
Erin Furr-Stimming, MD, FAAN (University of Texas Health Science Center-Houston)	Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Michael J. Fox Foundation. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedPage. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PTC Therapeutics. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedPage. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Wave Life Sciences. Dr. Furr-Stimming has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva Pharmaceuticals. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for PTC Therapeutics. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Wave Life Sciences. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Latus Bio. The institution of Dr. Furr-Stimming has received research support from Roche/Genetech. The institution of Dr. Furr-Stimming has received research support from Uniqure. The institution of Dr. Furr-Stimming has received research support from CHDI. The institution of Dr. Furr-Stimming has received research support from Huntington Study Group/Neurocrine Bioscienes. The institution of Dr. Furr-Stimming has received research support from NIH/University of Iowa. The institution of Dr. Furr-Stimming has received research support from Sage Therapeutics. The institution of Dr. Furr-Stimming has received research support from HDSA. Dr. Furr-Stimming has received publishing royalties from a publication relating to health care. Dr. Furr-Stimming has received publishing royalties from a publication relating to health care. Dr. Furr-Stimming has a non-compensated relationship as a Committee member with AAN UES Committee that is relevant to AAN interests or activities.
Daniel O. Claassen, MD, FAAN (Vanderbilt University Medical Center)	Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spark . The institution of Dr. Claassen has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Alterity. Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for University of Michigan. Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for HD Insights. The institution of Dr. Claassen has received research support from NIH. The institution of Dr. Claassen has received research support from CHDI. The institution of Dr. Claassen has received research support from HDSA. The institution of Dr. Claassen has received research support from Department of Defense. The institution of Dr. Claassen has received research support from CHDI. The institution of Dr. Claassen has received research support from Genentech/ Roche.
Elise Kayson, NP	Ms. Kayson has nothing to disclose.
Raja Mehanna, MD (University of Texas Health Science Center At Houston-McGovern Medical School)	Dr. Mehanna has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Mehanna has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. The institution of Dr. Mehanna has received research support from Cerevel. The institution of Dr. Mehanna has received research support from Neurocrine.
Shree Karpuram, MD	Mr. Karpuram has nothing to disclose.
Jody Goldstein, BS	Miss Goldstein has nothing to disclose.
Sean Hinton, PhD (Neurocrine Biosciences)	Dr. Hinton has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Dr. Hinton has stock in Neurocrine Biosciences, Inc..
Olga Klepitskaya, MD, FAAN (Neurocrine Biosciences, Inc)	Dr. Klepitskaya has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Dr. Klepitskaya has stock in Neurocrine Biosciences.
Hui Zhang (Neurocrine Bioscience)	Hui Zhang has received personal compensation for serving as an employee of Neurocrine Bioscience Inc..
Eduardo Dunayevich	Eduardo Dunayevich has received personal compensation for serving as an employee of Neurocrine Biosciences. Eduardo Dunayevich has stock in Neurocrine Biosciences.
Grace L. Liang, MD	Dr. Liang has received personal compensation for serving as an employee of Neurocrine Biosciences. Dr. Liang has stock in Neurocrine Biosciences.

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