H. Lundbeck A/S: Lundbeck presents new Vyepti® (eptinezumab) and bocunebart migraine portfolio data at EAN 2026

• Five migraine presentations will showcase Lundbeck's current and future approaches to migraine prevention, including new data for eptinezumab and Phase IIb PROCEED primary data for the investigational treatment, bocunebart
• Eptinezumab data explore patient-centered outcomes in chronic migraine beyond traditional endpoints, including acute medication use, psychological well-being, and workplace productivity
• Late breaker bocunebart presentation will provide further insight into pituitary adenylate cyclase-activating polypeptide (PACAP) pathway inhibition as a potential novel approach to migraine prevention in patients with prior preventive treatment failures
• Lundbeck's EAN 2026 program underscores the company's commitment to addressing the broader burden of the disease and continued scientific innovation around existing unmet needs

Valby, Denmark, Wednesday 24 June 2026 - H. Lundbeck A/S (Lundbeck) today announced that new migraine clinical data will be presented at the European Academy of Neurology (EAN) Congress 2026, taking place 27-30 June in Geneva, Switzerland. The presentations will include new analyses of eptinezumab data, exploring outcomes that reflect the wider burden of chronic migraine beyond migraine frequency alone. Lundbeck will also present Phase IIb PROCEED primary data for bocunebart, an investigational treatment targeting pituitary adenylate cyclase-activating polypeptide (PACAP) in development for migraine prevention.

Together, these EAN presentations highlight Lundbeck's dual focus in migraine: optimizing the use of current preventive treatment options while advancing future therapeutic approaches for people who continue to experience substantial disease burden.

Bocunebart data provide insight into PACAP pathway inhibition in migraine prevention
Among the highlights at EAN 2026 are data for bocunebart, a monoclonal antibody (mAb) designed to inhibit PACAP, a neuropeptide implicated in migraine pathophysiology distinct from anti-calcitonin gene-related peptide (aCGRP). PROCEED evaluated the efficacy, safety, dosing and route of administration of bocunebart in adults with migraine for whom one to four prior preventive treatments had failed.

"The presentation advances the evolving scientific understanding of PACAP pathway inhibition as a potential novel approach to migraine prevention for patients that continue to experience suboptimal disease control despite current preventive treatment options" said Andrew Blumenfeld MD, Cedars Sinai Los Angeles and presenter of the PROCEED findings at EAN 2026.

Eptinezumab data highlight patient-centered measures of migraine prevention
Lundbeck will also present new analyses from the Phase III SUNRISE and Phase IV RESOLUTION trials on eptinezumab, exploring treatment outcomes that reflect the wider clinical, functional and psychological burden of migraine.

Three presentations from the RESOLUTION trial will focus on adults living with chronic migraine and medication-overuse headache (MOH), a patient population in which migraine prevention is complicated by frequent headache, high acute medication use and substantial disease burden.

The analyses will examine treatment outcomes with eptinezumab across different European countries, patterns of acute medication use over time, and changes in symptoms of anxiety and depression that commonly accompany chronic migraine. In addition, the SUNRISE analysis will explore the impact of eptinezumab on workplace productivity and activity impairment in chronic migraine across regions in Asia and Europe.

"The burden of migraine extends well beyond the number of headache days. For many people living with migraine, the disease can affect multiple aspects of daily life, yet these impacts are not always fully captured in traditional measures of treatment benefit," said Johan Luthman, Executive Vice President and Head of Research & Development at Lundbeck. "At EAN 2026, we are presenting data that reflect a broader view of migraine prevention, while also advancing scientific understanding of PACAP pathway inhibition through our investigational molecule bocunebart. Together, these presentations reflect Lundbeck's commitment to advancing brain health in areas of unmet need."

Details of Lundbeck presentations at EAN 2026

About migraine
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound.[1] Not only is migraine painful but also imposes both a social and financial burden. Migraine has a profound impact on patient functioning including relationships with family/friends, leisure activities, household production and work productivity.

Migraine is one of the most prevalent neurological diseases for which medical treatment is sought and is considered the leading cause of disability for people under the age of 50 and the 2nd leading cause of disability worldwide.[2]^,[3] Repeated migraine attacks, and often the constant fear of the next one, damage family life, social life and work life. As migraine frequency and severity increase, attacks become harder to control, requiring patients to take more headache medication while experiencing less relief. This cycle contributes to a greater disease burden and, without appropriate preventive management, can lead to further worsening and chronification of migraine.[4]

About Vyepti® (eptinezumab)
Eptinezumab is a humanized mAb that binds to CGRP which was developed for intravenous (IV) administration. The efficacy and safety of eptinezumab 100 mg and 300 mg was investigated in two Phase III clinical trials (PROMISE-1 in episodic migraine[5] and PROMISE-2 in chronic migraine).[6] In both trials, eptinezumab met its primary endpoint of reducing mean monthly migraine days (MMD) over weeks 1-12 in both episodic and chronic migraine. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Approximately 8% of patients on 300 mg, 6% of patients on 100 mg and 6% of patients on placebo in PROMISE-1 and PROMISE-2 experienced nasopharyngitis. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions.

VYEPTI (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in more than 30 markets worldwide.

About the SUNRISE trial
SUNRISE (NCT04921384) was an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled Phase III trial, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment.² The trial enrolled 983 adult participants who were randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo.

The primary endpoint was the change from baseline in monthly migraine days (MMDs) during Weeks 1-12. Key secondary endpoints included the achievement of a ≥ 50% reduction in MMDs over Weeks 1-12, achievement of a ≥ 75% reduction in MMDs over Weeks 1-4 and Weeks 1-12, and the percentage of participants experiencing a migraine on Day 1. Other secondary and exploratory endpoints assessed overall migraine responder rates, long-term maintenance of effect, and the safety and tolerability of eptinezumab in this patient population. The trial was conducted to support marketing authorization across Asia.

About the RESOLUTION trial
The RESOLUTION trial (NCT05452239) was a Phase IV, multi-national, randomized, double-blind, placebo-controlled trial. The trial enrolled 608 participants with dual diagnoses of chronic migraine and MOH, and participants were randomly allocated to one of two treatment groups, brief educational intervention (BEI) and eptinezumab (100 mg; n = 305) or BEI and placebo (n = 303), in a 1:1 ratio.

RESOLUTION is the first randomized controlled trial to assess the efficacy of an anti-CGRP treatment in combination with structured patient education in chronic migraine and MOH. The primary endpoint was the change from baseline in monthly migraine days over weeks 1-4. Key secondary endpoints included change from baseline in average daily pain assessment score (as accessed by 3-point pain intensity scale, mild, medium, severe) and change from baseline in acute medication use over 1-12 weeks.  Other secondary and exploratory endpoints assessed monthly migraine days over weeks 1-12, MOH remission, transition from chronic to episodic migraine, reductions in headache-related burden, migraine-related disability, work productivity loss, activity impairment, and the safety and tolerability of eptinezumab in this patient population. The participants in the RESOLUTION trial were mainly from European countries.

About bocunebart
Bocunebart is an investigational mAb with a novel mechanism of action. It was engineered to bind to and inhibit the signaling of PACAP, a neuropeptide implicated in migraine pathophysiology. This mechanism operates through a pathway distinct from that targeted by anti-CGRP therapies.[7] Bocunebart met its primary endpoint in the Phase IIb PROCEED and is being investigated for the preventive treatment of migraine as a potential alternative approach to existing treatment classes.

Bocunebart is not approved by the US Food and Drug Administration (FDA) or any other regulatory agency, and the efficacy and safety of bocunebart have not been established.

About the PROCEED migraine trial
The PROCEED (NCT06323928) trial assessed the efficacy, safety, and tolerability of bocunebart versus placebo when administered once monthly for three months. The Phase IIb trial was designed to inform dose selection and route of administration for future development. In the IV part of PROCEED, a total of 429 patients from 14 countries were treated. The primary efficacy endpoint was defined as the difference between bocunebart and placebo in mean change from baseline in MMDs over Weeks 1 to 12.

The target population for this trial included adults with migraine according to the International Classification of Headache Disorders, Third Edition (ICHD-3) who had experienced treatment failure with one to four different preventive migraine medications within the past 10 years.

Contacts

About H. Lundbeck A/S
Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn.
 

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