Dysport Becomes First Botulinum Toxin to Achieve Positive Phase III Results in Both Episodic and Chronic Migraine
核心洞察
Ipsen's Dysport (abobotulinumtoxinA) met primary endpoints in both the E-BEOND and C-BEOND Phase III trials, demonstrating statistically significant reductions in monthly migraine (搜索) days versus placebo.
This marks the first time a botulinum toxin has shown statistically significant efficacy in a Phase III trial for episodic migraine (搜索), positioning Dysport as a potential first-in-class preventive therapy.
The BEOND program enrolled 1,510 patients across 120 centers, with Dysport showing a safety profile consistent with its well-established use and no new safety signals.
Ipsen announced on July 9, 2026, that its Phase III BEOND migraine (搜索) program evaluating Dysport (abobotulinumtoxinA) for the prevention of both episodic and chronic migraine in adults has delivered positive topline results. Both the E-BEOND trial for episodic migraine and the C-BEOND trial for chronic migraine met their primary endpoints, achieving a statistically significant reduction in monthly migraine days compared to placebo.
The E-BEOND results represent a landmark achievement: this is the first Phase III trial in which any botulinum toxin has demonstrated statistically significant efficacy in episodic migraine (搜索). Together with the positive C-BEOND results, the BEOND program becomes the first Phase III clinical program to demonstrate efficacy of a botulinum toxin across both episodic and chronic migraine.
"These results represent a significant advance in the development of botulinum toxin therapies for migraine (搜索)," said Christelle Huguet, PhD, EVP and Global Head of R&D at Ipsen. "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."
Trial Design and Scope
The BEOND Phase III program comprised two randomized, multi-center, placebo-controlled trials: C-BEOND (NCT06047444) and E-BEOND (NCT06047457). Together, the trials enrolled 1,510 patients across 120 centers worldwide. The primary endpoint for both trials was the change from baseline in the number of monthly migraine (搜索) days at week 24, measured over weeks 21 to 24. An extension phase, in which all participants receive Dysport for two treatment cycles, is ongoing and will continue to week 48.
Safety Profile
Dysport was well-tolerated across both trials. Safety findings were consistent with the well-established use of Dysport in its currently approved indications, and no new or unexpected safety signals were identified.
Addressing a Significant Unmet Need
Migraine (搜索) is a complex neurological disease estimated to impact approximately 14% of the world's population, according to a Global Burden of Disease study published in Cell Reports Medicine. People living with migraine experience recurring throbbing headache pain, nausea, vomiting, and sensitivity to light, sound, touch, and smell — symptoms that can have life-long impacts on patients and their families.
Episodic migraine (搜索), defined in the E-BEOND trial as experiencing up to 14 headache days per month of which at least 6 are migraine days, represents a substantially larger patient population than chronic migraine, which is defined as experiencing headaches on 15 or more days per month with at least 8 migraine days.
"Preventive treatment options for episodic migraine (搜索) remain limited. These clinical trial results are encouraging because they suggest a potential new preventative therapy that, if approved, may benefit a broad group of patients," said Dr. Jessica Ailani, MD, Clinical Professor of Neurology at MedStar's Georgetown University Hospital, Director of the MedStar Georgetown Headache Center, and Principal Investigator for the E-BEOND trial.
Dr. Cristina Tassorelli, MD, Professor and Chair of Neurology and Director of the Department of Brain and Behavioral Sciences at the University of Pavia, and Principal Investigator for the C-BEOND trial, added: "These Phase III topline results position Dysport as the first botulinum toxin to demonstrate efficacy for both episodic and chronic migraine (搜索) prevention, supporting an advance in treatment options for patients."
About Dysport
Dysport (abobotulinumtoxinA) is an injectable botulinum neurotoxin type A (搜索) (BoNT-A) product derived from Clostridium bacteria that inhibits the effective transmission of nerve impulses, thereby reducing muscular contractions. It is supplied as a lyophilized powder and currently holds marketing authorization in approximately 90 countries, with more than 30 years of clinical experience and over 21 million treatment years of patient experience. Dysport labels and approved indications vary by country.
Detailed findings from the BEOND program will be presented at a future scientific congress.