AbobotulinumtoxinA Meets Primary End Points in Phase 3 Program for Both Episodic and Chronic Migraine

According to a new company update, Ipsen announced topline results from the phase 3 BEOND program, which comprised the C-BEOND study (NCT06047444) and the E-BEOND study (NCT06047457), for migraine prevention. Findings showed that in both studies, abobotulinumtoxinA (Dysport) met its primary end point, demonstrating a significant reduction in migraine days (MMD) compared with placebo in adults with episodic and chronic migraine.¹

"Preventive treatment options for episodic migraine remain limited," principal investigator for the E-BEOND trial Jessica Ailani, MD, clinical professor of neurology at MedStar Georgetown University Hospital, said in a statement.¹ "These clinical trial results are encouraging because they suggest a potential new preventative therapy that, if approved, may benefit a broad group of patients."

Trial Design and Primary Outcomes

The BEOND program enrolled 1510 adults across 120 centers in the 2 randomized, multi-center, placebo-controlled trials C-BEOND and E-BEOND. The shared primary end point for both trials was the change from baseline in MMD at week 24, assessed over weeks 21 through 24. The company reported that both trials met this primary end point versus placebo.

“These Phase III topline results position Dysport as the first botulinum toxin to demonstrate efficacy for both episodic and chronic migraine prevention, supporting an advance in treatment options for patients,” principal investigator for the C-BEOND trial Cristina Tassorelli, MD, Professor and Chair of Neurology and Director of the Department of Brain and Behavioral Sciences at the University of Pavia in Italy, said in a statement.¹

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An open-label extension phase, in which all participants receive abobotulinumtoxinA for 2 additional treatment cycles, will continue through week 48; full data from that phase are pending. Across both trials, abobotulinumtoxinA was described as well-tolerated, with no new or unexpected safety signals identified. The observed safety profile was consistent with the established use of the agent in its currently approved indications.

“These results represent a significant advance in the development of botulinum toxin therapies for migraine,” Christelle Huguet, PhD, EVP and Global Head of R&D, said in a statement.¹ “BEOND is the first Phase III program to demonstrate efficacy of a botulinum toxin in both episodic and chronic migraine. Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population.”

Disease Burden and Clinical Context

Migraine is estimated to affect approximately 14% of the global population, roughly 1.16 billion people as of 2021, and ranks second among neurological disorders in years lived with disability.² Episodic migraine, defined in E-BEOND as up to 14 headache days per month with at least 6 meeting migraine criteria, represents a substantially larger patient population than chronic migraine (15 or more headache days per month, at least 8 of which are migraine days). Both subtypes impose significant occupational, social, and functional burden.

Drug-Class Background

AbobotulinumtoxinA is a botulinum neurotoxin type A (BoNT-A) product derived from Clostridium bacteria that inhibits acetylcholine release at the neuromuscular junction, thereby reducing muscular contractions. The agent carries marketing authorization in approximately 90 countries across multiple indications and has accumulated more than 21 million treatment-years of patient experience. In the United States, abobotulinumtoxinA is currently approved for cervical dystonia in adults and lower-limb spasticity in pediatric patients 2 years and older.³

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REFERENCES
1. Dysport® is the first botulinum toxin to achieve positive topline Phase III results in both episodic and chronic migraine. News release. Ipsen. July 9, 2026. Accessed July 9, 2026. https://www.ipsen.com/press-release/dysport-is-the-first-botulinum-toxin-to-achieve-positive-topline-phase-iii-results-in-both-episodic-and-chronic-migraine-3324543/
2. Wijeratne T, Oh J, et al. Global, regional, and national burden of headache disorders, 1990-2021, with forecasts to 2050: A Global Burden of Disease study 2021. Cell Rep Med. 2025;6(10):102348. doi:10.1016/j.xcrm.2025.102348
3. Ipsen Announces FDA Approval of Dysport®(abobotulinumtoxinA) for the Treatment of Upper LimbSpasticity in Children, Excluding Cerebral Palsy. News release. Ipsen. September 26, 2019. Accessed July 9, 2026. https://www.ipsen.com/us/press-releases/ipsen-announces-fda-approval-of-dysportabobotulinumtoxina-for-the-treatment-of-upper-limbspasticity-in-children-excluding-cerebral-palsy/