Abstract Details

Title Immunogenicity of DaxibotulinumtoxinA for Injection in Adults with Cervical Dystonia from a Phase 2 Dose-Escalation Multicenter Study

Topic Movement Disorders

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-012

Objective The efficacy and safety of daxibotulinumtoxinA for injection (DAXI), a 150 kDA botulinum neurotoxin A (BoNTA) formulated with a proprietary stabilizing excipient RTP004, in adults with cervical dystonia (CD) have been described.^1.This report focuses on the immunogenicity of DAXI.

Background NA

Design/Methods

BoNT-naïve or previously treated adults with moderate to severe CD were enrolled & given one treatment of DAXI. Neutralizing antibody (nAB) status was determined before injection at Baseline, Week 4 and Week 24 using a high sensitivity ELISA screening assay, a high specificity ELISA confirmation assay with AB titer quantification & the lethality assay for final confirmation (the mouse protection assay).

Results A total of 34 subjects (mean age: 56 years; 76% female; 59% [20/34] BoNT-naïve and 41% [14/34] were previously treated) enrolled in the study. At baseline, the mean Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score was 44; mean DAXI dose administered (range): 244 (100 – 450) units. Antibody screen was done on all serum samples (Baseline, Week 4, and Week 24) and 26% screened positive; however, only 3 samples (Baseline, Week 4, and Week 24) from 1 subject had nAB, confirmed by the lethality assay. This was a subject previously treated with Botox 650 U who had a nAB titer of 2 at baseline. This subject was given one treatment of DAXI 450 U, and the titers doubled at Week 4 and Week 24. This subject’s response to DAXI (reduction in TWSTRS-Total score from baseline) was 16.8 (32%) at Week 4 and 10.8 (20%) at Week 24. Overall, no BoNT-naïve subjects (0/20) developed nAB to DAXI after one treatment; 1 of 14 subjects previously treated with BoNT had an increase in nAB titer from baseline after treatment.

Conclusions The low rate of DAXI immunogenicity is comparable to other BoNTA products. Longer-term (>2 years) studies are needed to confirm these findings.

Authors/Disclosures
Allison Brashear, MD, MBA, FAAN (Univeristy of Buffalo) PRESENTER	Dr. Brashear has received personal compensation for serving as an employee of McKnight Brain Res Found. Dr. Brashear has received personal compensation for serving as an employee of American Board of Psychiatry and Neurology. Dr. Brashear has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for ABPN. Dr. Brashear has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for McKnight Brain Research Foundation i. Dr. Brashear has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Care Directions- start up . Dr. Brashear has stock in Caredirections . The institution of Dr. Brashear has received research support from NINDS. Dr. Brashear has received publishing royalties from a publication relating to health care. Dr. Brashear has received personal compensation in the range of $500-$4,999 for serving as a Special government employee and study section reviewer with NIH. Dr. Brashear has received personal compensation in the range of $0-$499 for serving as a Adminstrative board -travel reimbursement with AAMC.
Daniel D. Truong, MD, FAAN (PMDI)	The institution of Dr. Truong has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. The institution of Dr. Truong has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. The institution of Dr. Truong has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. The institution of Dr. Truong has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Truong has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Truong has received research support from Abbvie. The institution of Dr. Truong has received research support from Aeon. The institution of Dr. Truong has received research support from Biogen. The institution of Dr. Truong has received research support from Bukwang. The institution of Dr. Truong has received research support from Cerevel. The institution of Dr. Truong has received research support from Eli Lilly. The institution of Dr. Truong has received research support from Enterin. The institution of Dr. Truong has received research support from Ipsen. The institution of Dr. Truong has received research support from Lundbeck. The institution of Dr. Truong has received research support from Neurocrine. The institution of Dr. Truong has received research support from Neuroderm. The institution of Dr. Truong has received research support from Parkinson Foundation. The institution of Dr. Truong has received research support from Prilenia. The institution of Dr. Truong has received research support from Revance. The institution of Dr. Truong has received research support from Sunovion. Dr. Truong has received publishing royalties from a publication relating to health care. Dr. Truong has received publishing royalties from a publication relating to health care. Dr. Truong has a non-compensated relationship as a President with International Association for Parkinsonism and Related Disorders that is relevant to AAN interests or activities.
Cynthia L. Comella, MD, FAAN (Rush University Medical Center)	Dr. Comella has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vima. Dr. Comella has received publishing royalties from a publication relating to health care. Dr. Comella has received publishing royalties from a publication relating to health care.
Joseph Jankovic, MD, FAAN (Baylor College of Medicine)	Dr. Jankovic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Jankovic has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance, Allergan. The institution of Dr. Jankovic has received research support from Baylor College of Medicine. Dr. Jankovic has received research support from Abbvie. The institution of Dr. Jankovic has received research support from Abbvie.
Atul T. Patel	Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for IPSEN. Atul T. Patel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for IPSEN. The institution of Atul T. Patel has received research support from Abbvie. The institution of Atul T. Patel has received research support from IPSEN.
	No disclosure on file
Roman Rubio	Roman Rubio has received personal compensation for serving as an employee of Revance.
Mahan Chehrenama, DO (Manistee Therapeutics)	No disclosure on file

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