H. Lundbeck A/S (Lundbeck) today announced new data confirming long-term benefit of treatment with Vyepti[®] (eptinezumab) in migraine prevention. The findings from the DELIVER extension study are presented at the 65[th] Annual Scientific Meeting of the American Headache Society (AHS) on June 15-18, 2023, in Austin, Texas.

The DELIVER study confirmed the effectiveness of Vyepti in reducing migraine frequency and severity in adults with 2-4 previous treatment failures. The primary data from the placebo-controlled part of the study was published in Lancet Neurology[i]. The patients completing the placebo-controlled period in the DELIVER study were offered to participate in a 48-week open-label, dose-blinded extension period, and these data have now become available.

"The data presented at AHS shows Vyepti's long-term effectiveness which is an important aspect in the preventive treatment of migraine. The trial found that patients who received Vyepti treatment for up to one and a half years showed sustained and increasing improvements in their migraine symptoms as well as an overall improvement in their condition and quality of life. Moreover, the response of the patients who had been in the placebo arm in the DELIVER trial further confirm the fast onset of treatment effects with Vyepti. This is good news for patients, who suffer from migraine and are looking for a long-term solution," said Johan Luthman, EVP, and Head of Research & Development at Lundbeck.

In the extension phase of the DELIVER study, more than 90 percent of patients completed the 48-week extension period. Patients who switched from placebo to Vyepti experienced a decrease in monthly migraine days, severity, and impact scores, as well as a reduction in acute medication use to a level similar to what was observed in patients treated with Vyepti in the placebo-controlled period of the DELIVER study.

All treatment arms showed sustained reductions in monthly migraine days, with over 60 percent and more than 30 percent of patients experiencing ≥50% and ≥75% reduction from baseline, respectively, during weeks 61-72. No new safety concerns were identified.

The results from the extended DELIVER study confirm the long-term effectiveness of Vyepti treatment for up to 18 months, with marked and sustained reductions in migraine days, headache severity, and burden of migraine.

Scientific presentations from Lundbeck at AHS
Including the first display of data from the DELIVER extension study, Lundbeck is supporting a total of 9 abstracts which have been accepted for presentation at the AHS Annual Scientific Meeting 2023:

1. Starling, A et al.: Long-term effectiveness of eptinezumab in patients with prior preventive migraine treatment failures. Poster presentation #114.
2. Blumenfeld, A et al.: Long-term effectiveness of eptinezumab in treatment of patients with chronic migraine and medication-overuse headache. Poster presentation #115.
3. Talon, B et al.: Persistence to onabotulinumtoxinA and calcitonin gene-related peptide monoclonal antibody therapy among patients with migraine: A retrospective cohort study. Poster presentation #144.
4. Argoff, C et al.: Real-world evidence of the effectiveness and satisfaction with eptinezumab treatment in patients with chronic migraine. Poster presentation #165.
5. Argoff, C et al.: Patients and physicians report a positive infusion experience with eptinezumab in the real-world setting. Poster presentation #140.
6. Starling, A et al.: Health concerns and treatment perspectives among US adults with current versus previous high-frequency headache/migraine and acute medication overuse: The Harris Poll Migraine Report Card Survey. Poster presentation #90.
7. Starling, A et al.: Race/ethnicity-based perceptions of and experience with migraine-related burden, treatment, and care in people with high-frequency headache/migraine and high acute medication use. Oral presentation. 17 June, 7:30-9:30am.
8. Buse, DC et al.: Headache-related stigma in adults experiencing high-frequency headache/migraine and high acute medication use: Results of the Harris Poll Migraine Report Card Survey. Poster presentation #89.
9. Curran, Y et al.: Patient awareness and provider communication about medication-overuse headache among patients with migraine. Poster presentation #137.

Contacts

Thomas Mikkel Mortensen Palle Holm Olesen
Media Relations Lead, Corp. Communication Vice President, Investor Relations
THMR@lundbeck.com PALO@lundbeck.com
+45 30 83 30 24 +45 30 83 24 26

About the DELIVER study
DELIVER (NCT04418765) was a phase lllb, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Vyepti in patients with chronic or episodic migraine[i]. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior classes of traditional oral migraine preventive treatments. Patients who experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians' confirmation specific to each treatment in the past 10 years.

In the study, 892 patients were randomized to receive eptinezumab 100 mg or 300 mg or placebo by intravenous (IV) infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550 (61.8%), 277 (31.1%), and 60 (6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures, respectively. The primary endpoint was change from baseline in the number of monthly migraine days over Weeks 1-12. Key secondary endpoints included response rates as patients with 50% or greater reduction from baseline in MMDs (Weeks 1-12), response rates of patients with 75% or greater reduction from baseline in MMDs (Weeks 1-12) and change from baseline in the number of MMDs (Weeks 13-24). Other secondary endpoints assessed the effect of Vyepti vs placebo on 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, Health care resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI) [ii],[iii].

The DELIVER extension study
For the 48-week dose-blinded extension, patients who had received eptinezumab in the placebo-controlled period continued at their randomized dose (100 mg or 300 mg); patients who had received placebo in the double-blind phase started eptinezumab 100 mg or 300 mg. Eptinezumab was administered intravenously once every 3 months for four additional doses.

Changes from baseline in the number of monthly migraine days (MMDs) was the primary efficacy endpoint of the extension study, and the percentages of patients achieving ≥50% reduction in MMDs (≥50% response) and ≥75% reduction in MMDs (≥75% response) during Weeks 25-36, 37-48, 49-60, and 61-72 were predefined secondary study endpoints. These endpoints were derived from data collected via the eDiary which also assessed changes in headache severity and acute medication use. The change from baseline in disease impact was assessed with the 6-item headache impact test (HIT-6) total score at Weeks 36, 48, 60, and 72 which was also a predefined secondary endpoint.

About Vyepti® (eptinezumab)
Vyepti is a humanized monoclonal antibody that binds to CGRP which was purposefully developed for IV administration. The efficacy and safety of Vyepti was evaluated in two phase III clinical trials (PROMISE-1 in episodic migraine[iv] and PROMISE-2 in chronic migraine[v]), where Vyepti met its primary endpoint of decrease in MMDs over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion. For the initial approval, the safety of Vyepti was evaluated in 2,076 adult patients with migraine who received at least one dose of Vyepti. 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. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti 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, Vyepti was granted marketing authorization by the European Medicines Agency (EMA).

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[vi]. It is estimated to affect approximately 39 million people in the U.S. and more than 1 billion worldwide and impacts three times as many women than men. Migraine is the second leading cause of years lived with disability (YLD) among all diseases, and it is the top YLD cause among patients aged 15 to 49 years, according to the Global Burden of Disease study[vii]. As the most prevalent neurological disorder in people aged <50 years, migraine imposes both a social and financial burden. In Europe, migraine alone affects close to 50 million people costing the economy EUR 18 billion annually according to the Cost of Brain Disorders in Europe[viii] study and this is without the indirect cost associated with presenteeism (i.e., productivity losses due to reduced efficiency of persons who are not sufficiently ill to be absent from work). Repeated headache attacks, and often the constant fear of the next one, damage family life, social life, and work life. Furthermore, frequent use of acute migraine treatments may leave patients experiencing, or at risk of developing, medication overuse headache.

About H. Lundbeck A/S
Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

For additional information, we encourage you to visit our corporate site www.lundbeck.com (https://www.lundbeck.com/global) and connect with us via LinkedIn (https://www.linkedin.com/company/lundbeck/).

References
[i] Ashina M, et al. Lancet Neurol. 2022 Jul;21(7):597-607.

[ii] Goadsby PJ et al. Eur J Neurol. 2023 Apr;30(4):1089-1098

[iii] Barbanti P et al. J Headache Pain. 2022 Dec 2;23(1):153

[iv] Ashina M, et al. Cephalalgia. 2020 Mar;40(3):241-254.

[v] Lipton RB, et al. Neurology. 2020 Mar 31;94(13):e1365-e1377.

[vi] Villalón CM. Pharmacol Ther. 2009;124(3):309-323.

[vii] Steiner TJ, et al. J Headache Pain. 2018;19(1):17.

[viii] Gustavsson A, et al. Eur Neuropsychopharmacol. 2011 Oct;21(10):718-79.