Ipsen today announced positive topline results from its Phase III BEOND migraine program evaluating Dysport (abobotulinumtoxinA) for the prevention of episodic and chronic migraine in adults. Both the E-BEOND and C-BEOND trials met their primary endpoints, showing a reduction in monthly migraine days versus placebo. The results position Dysport as the first botulinum toxin to demonstrate efficacy in both episodic and chronic migraine prevention.

The E-BEOND results mark the first Phase III trial where a botulinum toxin has shown statistically significant efficacy in episodic migraine. Combined with the positive C-BEOND results, the BEOND program is the first to demonstrate efficacy of a botulinum toxin in preventing both episodic and chronic migraine. Dysport was well-tolerated across both trials, with safety findings consistent with its established profile and no new signals identified.

"These results represent a significant advance in the development of botulinum toxin therapies for migraine," 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 Details

The BEOND Phase III program consisted of two randomized, multi-center, placebo-controlled trials: C-BEOND (NCT06047444) and E-BEOND (NCT06047457). The trials enrolled 1,510 patients across 120 centers. The primary endpoint for both trials was the change from baseline in the number of monthly migraine days at week 24, measured over weeks 21 to 24.

An Extension Phase of the BEOND trials, where all participants receive Dysport for two treatment cycles, will continue to week 48. Detailed findings from the program will be presented at a future scientific congress.

About Migraine and Dysport

Migraine is a complex neurological disease estimated to impact approximately 14% of the world’s population. Episodic migraine is defined as experiencing up to 14 headache days per month, with at least 6 being migraine days. Chronic migraine is defined as experiencing headaches on 15 or more days per month, with at least 8 migraine days.

Dysport (abobotulinumtoxinA) is an injectable form of botulinum neurotoxin type A. It inhibits the transmission of nerve impulses, reducing muscular contractions. AbobotulinumtoxinA has marketing authorization in approximately 90 countries, with more than 30 years of clinical experience and over 21 million treatment years of patient experience.

Ipsen has entered into a definitive share purchase agreement to acquire Memo Therapeutics AG for 200 million EUR on a cash-free and debt-free basis, with deferred payments potentially bringing total consideration to over 700 million EUR. The acquisition centers on potravitug, a first-in-class monoclonal antibody targeting BK polyomavirus (BKPyV) reactivation in kidney transplant recipients, a serious complication with no approved targeted treatments. The transaction is expected to close during Q3 2026, subject to customary closing conditions, and its impact is factored into Ipsen’s current full-year guidance.

Clinical data supports pivotal trial

The Phase II SAFE KIDNEY II trial, the largest placebo-controlled study for BKPyV-associated nephropathy (BKPyVAN) with 95 patients across 22 U.S. sites, demonstrated the efficacy of potravitug. Topline results showed higher rates of viral load reduction or undetectable levels compared to placebo at week 20, alongside histological improvement. By week 38, 24.4% of treated patients achieved undetectable BKPyV-DNAemia versus 13.0% in the placebo group. Additionally, >2-log10 viral load reductions occurred in 40.3% of the potravitug group versus 24.7% of the placebo group. Biopsy-proven BKPyVAN declined from 51.2% to 31.6% by week 20 in the treatment arm, with no change in the placebo group. The drug was well tolerated, with no treatment-related serious adverse events reported.

Transaction structure and strategic fit

Under the agreement terms, Memo Therapeutics AG's shareholders will receive the upfront payment at closing, with additional contingent payments based on development, regulatory approval, and sales milestones. As a condition precedent, assets and employees not related to potravitug will be transferred to a newly incorporated company, Memorises Bio, which will be retained by Memo Therapeutics AG's shareholders. This carve-out includes the collaboration with CSL on the Rec-IgG Project and the DROPZYLLA antibody discovery platform. Christelle Huguet, PhD, EVP, Head of R&D at Ipsen, stated the acquisition reinforces the company's commitment to transformative solutions for patients with significant unmet needs.

Potravitug mechanism and regulatory status

Potravitug is a monoclonal antibody directed against the BK virus VP1 capsid protein, blocking viral attachment and cellular entry to prevent infection and replication. The U.S. Food and Drug Administration (FDA) granted fast-track designation to potravitug in May 2023, and it received orphan drug designation in the European Union in December 2025. The totality of evidence from the Phase II trial supports the initiation of a pivotal Phase II/III SAFE KIDNEY III trial later this year. Erik van den Berg, CEO of Memo Therapeutics AG, highlighted that Ipsen's expertise in rare diseases will ensure the breakthrough asset reaches its full potential.