Clinical Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines: Pooled Data from the SAKURA Phase 3 Trials

Clinical Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines: Pooled Data from the SAKURA Phase 3 Trials

DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A product containing daxibotulinumtoxinA with a stabilizing excipient peptide (RTP004). DAXI immunogenicity was assessed in three phase 3 glabellar line studies (two placebo-controlled, single-dose studies and an open-label rep...

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Bibliographic Details
Published in:Toxins 2023-01, Vol.15 (1), p.60
Main Authors: Gallagher, Conor J, Bowsher, Ronald R, Clancy, Amanda, Dover, Jeffrey S, Humphrey, Shannon, Liu, Yan, Prawdzik, Gregg
Format: Article
Language:eng
Subjects:
Animals
Antibodies
Antibodies, Neutralizing
Binding
Botulinum toxin
Botulinum toxin type A
botulinum toxins
Botulinum Toxins, Type A - therapeutic use
Clinical trials
DAXI
daxibotulinumtoxinA
Double-Blind Method
Drug dosages
Evaluation
Immunogenicity
Injection
Injections
Mice
Neuromuscular Agents - therapeutic use
Neutralizing
neutralizing antibodies
Peptides
Placebos
Proteins
Skin Aging
Smooth muscle
Toxins
Treatment Outcome
type A
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Summary:DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A product containing daxibotulinumtoxinA with a stabilizing excipient peptide (RTP004). DAXI immunogenicity was assessed in three phase 3 glabellar line studies (two placebo-controlled, single-dose studies and an open-label repeat-dose safety study). Binding antibodies to daxibotulinumtoxinA and RTP004 were detected by validated ELISAs. Samples positive for daxibotulinumtoxinA-binding antibodies were evaluated further for titer and neutralizing antibodies by mouse protection assay. Overall, 2786 subjects received DAXI and 2823 subjects were exposed to RTP004 as DAXI (n = 2786) or placebo (n = 37). Treatment-related anti-daxibotulinumtoxinA binding antibodies were detected in 21 of 2737 evaluable subjects (0.8%). No subject developed neutralizing antibodies. Treatment-related anti-RTP004 binding antibodies were detected in 35 (1.3%) of 2772 evaluable subjects. Binding antibodies were generally transient, of low titer (
ISSN:2072-6651
2072-6651