H. Lundbeck A/S: Lundbeck announces positive results from phase III pivotal trial (SUNRISE) of Vyepti® (eptinezumab) in migraine prevention

• Vyepti® met all key secondary efficacy endpoints in the SUNRISE trial, and the treatment was generally well tolerated
• Beginning day 1 after infusion, Vyepti® lead to statistically significant reductions in the risk of experiencing migraine compared to placebo

H. Lundbeck A/S (Lundbeck) announced that Vyepti® (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III pivotal clinical trial predominantly conducted in Asia evaluating the efficacy and safety in patients with chronic migraine. Based on the trial results Lundbeck plans to initiate discussions with relevant regulatory authorities with the aim of making Vyepti available for people suffering from migraine across Asia.

In the SUNRISE trial, Vyepti met the primary endpoint showing statistically significant reductions in monthly migraine days (MMD) as compared with placebo. From baseline (average of 17 days) over weeks 1 through 12, mean reductions in MMDs were -7.5 for 300 mg and -7.2 for 100 mg compared to -4.8 days for placebo (p<0.0001 and p<0.0001 for 300 mg and 100 mg vs placebo, respectively). In addition, significantly greater proportions of patients achieved ≥50% reduction in monthly migraine days over weeks 1-12 with Vyepti 300 mg and 100 mg compared to placebo. Also confirming previous efficacy findings with Vyepti, more patients treated with Vyepti achieved ≥75% reduction in MMDs compared to placebo, and the SUNRISE trial confirmed early onset of preventive effects with significantly lower proportion of patients experiencing migraine on the day following infusion with Vyepti compared to placebo.

"Millions of people in Asia suffer from frequent and severe migraine, yet very few utilize preventive therapy due to limitations in efficacy, safety and tolerability in currently available therapies," said Johan Luthman, EVP and Head of R&D at Lundbeck. "I am very pleased with the outcome of the SUNRISE trial as patients in Asia also deserve more from their treatments, and these data show that Vyepti could be an important advancement in meeting the significant unmet need for patients to regain control of their lives. The results of the SUNRISE trial will be pivotal for our efforts to make Vyepti available for patients in Asia suffering from severe and disabling migraine".

The observed safety profile of Vyepti in the SUNRISE trial was generally similar to placebo, with the most common treatment-emergent adverse events (TEAEs) being COVID-19 and nasopharyngitis. The safety profile and the rates of TEAEs with Vyepti were consistent with previously reported trials.
 

About the SUNRISE trial

SUNRISE (NCT04921384) is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled phase III trial, to confirm the efficacy and safety of Vyepti in participants with chronic migraine who are eligible for preventive treatment. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days. Participants were randomly allocated to one of three treatment groups: Vyepti 300 mg, Vyepti 100 mg, or placebo. The double-blind, placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of Vyepti. The total trial duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks). Participants in Japan completing the SUNRISE trial were offered to continue in the SUNSET trial (NCT05064371) which consisted of an open-label treatment of 60 weeks (five infusions), and a Safety Follow-up Period (8 weeks).

The trial was initiated in May 2021 and was conducted in Mainland China, Georgia, Japan, Poland, Slovakia, South Korea, Spain and Taiwan. In the trial, 983 participants were randomized to receive Vyepti 100 mg or 300 mg or placebo by intravenous (IV) infusion.
 

About Vyepti® (eptinezumab)

Vyepti is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of Vyepti 100 mg and 300 mg was investigated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), where Vyepti met its primary endpoint of decrease in mean monthly migraine days (MMD) 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. The safety of Vyepti was evaluated in more than 2,000 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. 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 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). Today, Vyepti is launched in the U.S. market, as well as in more than 30 markets worldwide.
 

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. Not only is headache painful, but migraine also impose both a social and financial burden. Migraine has a profound impact on patient functioning including relationships with family/friends, leisure activities, household production and worker productivity. Migraine is one of the most prevalent neurological disease for which medical treatment is sought, and worldwide, is considered the leading cause of disability for people under the age of 50 and 2nd leading cause of disability worldwide[i][,] [ii]. 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. Despite equally high prevalence of migraine in Asian as compared western countries, significant unmet needs remain in terms of sufficient and appropriate diagnosis, and better management and therapies for treatment of migraine in East Asia[iii]. In China, an estimated 14.3% of adults are living with migraine. From this population, approximately 52.9% will visit hospitals and only 13.8% of them will be diagnosed with migraine[iv].
 

Contacts

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

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 approximately 5,500 employees in more than 50 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 (https://www.lundbeck.com/global) and connect with us via LinkedIn (https://www.linkedin.com/company/lundbeck/).
 

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[i] Steiner TJ, Stovner LJ, Vos T. et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain 2018; 19: 17.

[ii] Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring disability in headache disorders with WHO's classification of functioning, disability and health (ICF). J Headache Pain. 2005; 6(6): 429-440.

[iii] Takeshima, T., Wan, Q., Zhang, Y. et al. Prevalence, burden, and clinical management of migraine in China, Japan, and South Korea: a comprehensive review of the literature. J Headache Pain 2019; 20, 111

[iv] Guidelines for the diagnosis and treatment of migraine in China (2022 edition). Chinese Journal of Pain Medicine 2022, 28 (12)