Lundbeck to Present New Data at AAN 2022 Adding to Clinical Evidence Regarding VYEPTI

• Oral presentation of post hoc analysis of PROMISE 2 data suggests that improving to 4 or fewer monthly headache days may be a useful treatment goal for people with chronic migraine
• Poster presentation of exploratory analysis from PROMISE 2 showed VYEPTI was associated with greater declines in headache frequency and days of acute headache medication use vs. placebo in people dually diagnosed with chronic migraine and medication overuse headache
• Poster presentation of post hoc analysis of RELIEF study suggests VYEPTI showed greater acute migraine medication optimization and decreased headache-related impact compared to placebo
• A poster presentation will outline the study design of ALLEVIATE (trial-in-progress), the first study to evaluate the efficacy and safety of VYEPTI in patients with episodic cluster headache

DEERFIELD, Ill.--(BUSINESS WIRE)-- Lundbeck today announced new data from an oral abstract for VYEPTI^® (eptinezumab-jjmr), along with three poster presentations, are being presented at the 2022 Annual Scientific Meeting of the American Academy of Neurology (AAN), which is being held in person from April 2-7 and virtually from April 24-26. The findings are part of a post hoc analysis of one of two pivotal trials, PROMISE 2 (NCT02974153), a randomized, double-blind study that evaluated VYEPTI for the preventive treatment of chronic migraine. Results showed that a higher percentage of people with chronic migraine who experienced a reduction to 4 or fewer monthly headache days (MHDs) achieved improved health outcomes (headache impairment as measured by the 6-item Headache Impact Test (HIT-6) and improvements in Patient Global Impression of Change (PGIC)) and required less acute medication versus people with chronic migraine who experienced higher MHDs (5-9, 10-14, ≥15).¹ Study participants received VYEPTI 100 mg, 300 mg, or placebo; all treatment arms were pooled for the analysis.

“While current treatment goals for people with chronic migraine focus on responder rates such as a reduction in monthly migraine days, assessing the number of monthly headache days may be a more straightforward way to understand and communicate treatment goals to people living with migraine,” said Roger Cady, M.D., Vice President of the National Headache Foundation, and one of the lead study authors. “Based on this analysis from PROMISE 2, adapting to a treatment goal associated with improved headache symptoms and reduction of acute medication use offers an opportunity to have more meaningful ways to articulate how we get to better outcomes in migraine.”

The study (SC1.002) combined available HIT-6 and PGIC data, along with days of acute medication use, and organized that data based on the number of MHDs (≤4, 5-9, 10-14, ≥15) experienced during 4-week assessment periods, called patient-months. In the abstract, 67.6% of the months where people with chronic migraine experienced ≤4 MHDs were associated with “little to none” or “some” headache impairment (as measured by the HIT-6 total score), compared to 47.6%, 29.9%, and 13.9% of months where people with chronic migraine experienced 5-9, 10-14, and ≥15 MHDs, respectively.¹

In addition, 85.8% of these months (where people with chronic migraine experienced ≤4 MHDs) were associated with PGIC reports of feeling “very much” or “much” improved, vs. 69.9%, 49.6%, and 21.5% of months where people with chronic migraine experienced 5-9, 10-14, and ≥15 MHDs, respectively.¹ The use of acute medication for fewer than 10 days a month occurred less often in months with ≤4 MHDs (1.9%), compared to months with 5-9 (5.0%), 10-14 (49.6%), and ≥15 (74.1%) MHDs.¹

“As a leader in migraine and neurology, we are excited about the data supporting VYEPTI and recognize its importance in driving a broader conversation about evolving and improving migraine care,” said Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck. “We are leveraging our long-standing expertise in brain disease to focus on chronic migraine care and take approaches to redefine what it means to live with migraine.”

Additional Research Presented at AAN 2022
Along with the oral presentation of the post hoc PROMISE 2 results, Lundbeck is presenting three poster presentations from the PROMISE 2, RELIEF, and ALLEVIATE studies.

Changes in Acute Headache Medication Use in PROMISE 2 (P16.002)

An exploratory analysis of PROMISE 2 (NCT02974153) found that, among people with a dual diagnosis of chronic migraine and medication overuse headache (MOH), VYEPTI was associated with reduction in headache frequency and days of acute headache medication (AHM) use versus placebo. Overall, the proportion of days with headache and AHM use decreased from baseline to post-baseline by 29.1 percentage points in VYEPTI-treated patients vs. 18.4 percentage points in the placebo group. The proportion reporting no headache and no AHM use increased by 33.8 percentage points and 23.6 percentage points for VYEPTI and placebo groups, respectively.

VYEPTI Initiated During a Migraine Attack (P3.006)

In a post hoc analysis of RELIEF (NCT04152083), VYEPTI, when administered during an active migraine, was associated with improved acute migraine medication optimization and decreased headache-related impact compared to placebo. The analysis assessed a combined subgroup of people (VYEPTI 100mg, n=155; placebo, n=138) with migraine considered to be poor to very poor responders of acute medication at baseline (as measured by the 6-item Migraine Treatment Optimization Questionnaire (mTOQ-6)). At Week 4 of treatment, the percentage of people with migraine in the combined very poor and poor optimization subgroups (mTOQ-6 scores of 0-5) decreased by 26.6 percentage points in the VYEPTI group (from 68.6% to 42.0%) vs. 9.9 percentage points with placebo (from 59.5% to 49.6%).

Assessing the Efficacy and Safety of VYEPTI in Patients with Episodic Cluster Headache (P3.002)

Lundbeck highlights the study design for ALLEVIATE (NCT04688775), an in-progress investigational phase 3, parallel-group, double-blind, placebo-controlled, delayed-start, randomized study. This is the first study to evaluate the efficacy and safety of VYEPTI in people with episodic cluster headache. The trial is currently recruiting eligible people 18 to 75 years old with episodic cluster headache and a history of cluster headache bouts lasting at least 6 weeks. People will be randomized to, and treated with, intravenous VYEPTI 400 mg or placebo, then receive the alternate study drug at Week 4.

About VYEPTI^®
VYEPTI^® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion.

The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE 1 and chronic migraine in PROMISE 2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent 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 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions.

VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information.

Indication and Important Safety Information
VYEPTI^® (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults.

Important Safety Information

CONTRAINDICATIONS
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, have occurred with VYEPTI in clinical trials. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.

ADVERSE REACTIONS
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.

VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. VYEPTI is not approved for the acute treatment of migraine. For more information, please see Prescribing Information and Patient Information or visit www.VYEPTIHCP.com.

About the PROMISE 2 Study
The PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2 (PROMISE 2) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults with chronic migraine, defined as 15-26 headache days per month, of which at least 8 were migraine days.² A total of 1,072 people with chronic migraine received up to two treatments with VYEPTI 100 mg (n=356), VYEPTI 300 mg (n=350), or placebo (n=366), each administered via IV on Day 0 and at Month 3.² People with chronic migraine and medication overuse headache, with the exception of overuse of barbiturates or opioids, were eligible for inclusion in the study.²

About the RELIEF Study
In November 2019, Lundbeck sponsored the RELIEF study assessing the efficacy and tolerability of VYEPTI initiated during a migraine attack in people with 4 to 15 migraine days per month who by current guidelines would be candidates for preventive therapy.³ People were randomized to receive a single dose of VYEPTI or placebo in a 1:1 ratio (n=480) by a 30-minute IV infusion within 1 to 6 hours of onset of a diagnosed attack of migraine with or without aura.³ The total study duration was 4 to 12 weeks, including up to an 8-week screening period, with clinic visits occurring on Screening, Day 0 (dosing day; people with a migraine attack were treated with VYEPTI and followed at the study site for 4 hours after the infusion), and Week 4.³ People with migraine were allowed to utilize acute rescue medication at any time 2 hours after start of infusion and treated breakthrough migraines with their usual acute medications during the subsequent 4 weeks following. ³

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.⁴ It is estimated to affect approximately 39 million people in the U.S. and more than 1.3 billion worldwide, and impacts three times as many women than men.⁴ It is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among people aged 15 to 49 years, according to the Global Burden of Disease study.⁵ Migraine has a profound impact on peoples’ lives, their relationships, as well as their ability to carry out activities of daily living.⁶ More than 157 million workdays are lost each year in the U.S. due to migraine.⁴

About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global biopharmaceutical 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.

Our approximately 6,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several R&D programs and our products are available in more than 100 countries. We have research centers in Denmark and California and our production facilities are located in Denmark, France and Italy.

In the United States, Lundbeck employs more than 1,000 people focused solely on accelerating therapies for brain disorders. With a special commitment to the lives of patients, families and caregivers, Lundbeck US actively engages in a broad range of initiatives each year that support our patient communities.

For additional information, we encourage you to visit us at www.lundbeck.com/us, subscribe to our newsletter at Newsroom.LundbeckUS.com, and connect with us on LinkedIn at @LundbeckUS and Twitter at @LundbeckUS.

______________________
¹ Kaniecki R, et al. Patients With Chronic Migraine Improving to ≤5 Monthly Headache Days is an Effective Treatment Goal for CM. Presented at the Annual Scientific Meeting of the American Academy of Neurology, April 6, 2022.
² Lipton RB, Goadsby PJ, Smith J, et al. PROMISE-2: Efficacy and safety of eptinezumab in patients with chronic migraine. Neurology. 2020;94(13):e1365-e1377.
³ Winner PK, McAllister P, Chakhava G, et al. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021;325(23):2348-2356. doi:10.1001/jama.2021.7665
⁴ Migraine Research Foundation. Migraine Facts. Available at https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed February 23, 2022.
⁵ Steiner TJ, et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018;19(1):17.
⁶ Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 2007;68:343-349.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220402005014/en/