https://doi.org/10.55788/d9c18377
The UB-313 vaccine is projected to be less expensive than the currently available CGRP inhibitors, making it a more accessible treatment option for migraineurs. The longer-lasting effectiveness would also make it more convenient to use.
Dr Jean-Cosme Dodart (Vaxxinity Inc, FL, USA) presented the ongoing phase 1 trial on UB-313 (NCT05477095) assessing safety, immunogenicity and target engagement: capsaicin-induced increase in dermal blood flow [1]. It is a single-site, randomised, double-blind, placebo-controlled, multidose regimen study of UB-313 performed at the University Hospital in Leuven, Belgium. The study duration is 44 weeks, consisting of intramuscular injections of UB-313 or placebo at week 0 (baseline, day 1), week 4 and week 12, and follow-up. Participants are healthy men and women aged 18 to 55 years without migraine.
Immunogenicity studies of UB-313 were already conducted in animal models (rodents and monkeys). UB-313 was found to induce robust anti-CGRP antibodies across species. Affinity-purified antibodies bound human CGRP with high affinity, resulting in a (dose-dependent) functional inhibition of CGRP. The properties of antibodies from immunised animals were comparable with CGRP antibodies currently on the market. The specificity of the anti-CGRP antibodies for human CGRP was very high and UB-313-induced antibodies had a stronger effect on human CGRP than on rat CGRP, despite a single amino acid substitution between species.
Preclinical toxicology studies indicated UB-313 to be safe and well-tolerated. Adverse events were limited to injection site reactions and UB-313 seems to safely overcome immune tolerance.
- Dodart J-C. UB-313, an investigational CGRP vaccine for the prevention of migraine. ES1.005, AAN 2023 Annual Meeting, 22–27 April, Boston, USA.
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Table of Contents: AAN 2023
Featured articles
Letter from the Editor
Positive results for hereditary transthyretin-mediated amyloid polyneuropathy
Infectious Diseases
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Cognitive Impairment and Dementia
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Donanemab shows rapid and deep plaque clearance in early Alzheimer’s Disease
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Seizure forecasting and detection with wearable devices are feasible
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Headache and Migraine
Lecture on migraine: from the prodromal phase to future paradigm shifts
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A vaccine as a potentially safe and effective immunotherapy against CGRP
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Teriflunomide prevents conversion to MS in patients with RIS
Gold nanocrystals may be effective as adjunctive MS therapy
Muscle and Neuro-Muscular Disorders
First-ever ALS platform trial reports on outcomes of 4 treatments
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Stroke
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Artificial intelligence applications in neurology: seize the moment
Spinal cord stimulation eases painful diabetic neuropathy
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Severe sleep apnoea associated with white matter hyperintensities
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