H. Lundbeck A/S announced positive results from the SUNRISE phase III trial, demonstrating the efficacy and safety of eptinezumab (Vyepti®) in a predominantly Asian population with chronic migraine. The results were presented at the 11th Congress of the European Academy of Neurology in Helsinki on June 21, 2025.
The randomized, double-blind, placebo-controlled trial enrolled 983 participants and met all key primary and secondary endpoints. Patients receiving eptinezumab experienced statistically significant reductions in mean monthly migraine days (MMDs) compared with placebo, with improvements observed as early as day 1 and sustained through week 12.
Trial Results Show Substantial Migraine Reduction
In the SUNRISE trial, patients receiving eptinezumab demonstrated significantly fewer monthly migraine days, with the 300mg dose offering a -7.5 reduction in MMDs from week 1 through 12, and the 100mg dose showing a -7.2 reduction, compared to -4.8 with placebo (baseline MMD = 17, p<0.0001 for both doses versus placebo).
Notably, patients receiving either dose of eptinezumab were four times more likely to achieve a reduction of ≥75% in the number of migraine days per month compared to placebo within the first four weeks (p<0.0001). The treatment also demonstrated rapid onset of preventive efficacy, with more participants reporting being migraine-free as early as day 1 after receiving eptinezumab treatment compared to placebo (p<0.002 for 300mg dose; p<0.01 for 100mg dose).
Addressing Unmet Medical Needs in Asia
"Various treatments are recommended for patients with migraine in Asia, however utilization and adherence to migraine-specific treatment is relatively low. Access to effective treatments remains a significant unmet medical need for migraine prevention in Asia," said Johan Luthman, EVP and Head of R&D at Lundbeck.
The trial addresses a critical gap in migraine care across Asia. In China alone, an estimated 14.3% of adults live with migraine, yet only 52.9% visit hospitals and merely 13.8% receive a proper migraine diagnosis. Despite equally high prevalence of migraine in Asia compared to Western countries, significant unmet needs remain in terms of sufficient diagnosis and appropriate treatment management.
Safety Profile Consistent with Previous Studies
The safety profile of eptinezumab in the SUNRISE trial was generally similar to placebo and consistent with previous trials and current labeling information. The most common treatment-emergent adverse events were COVID-19 and nasopharyngitis. Patient-reported outcomes showed clinically meaningful improvements that were greater with eptinezumab than with placebo.
Trial Design and Regulatory Path Forward
The SUNRISE trial was conducted across multiple regions including Mainland China, Georgia, Japan, Poland, Slovakia, South Korea, Spain, and Taiwan. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days. Participants were randomly allocated to receive eptinezumab 300mg, eptinezumab 100mg, or placebo via intravenous infusion.
The study included a 12-week placebo-controlled period followed by an extension period where all participants received active treatment. The total trial duration was approximately 36 weeks, including screening, treatment, extension, and safety follow-up periods.
Dr. Patricia Pozo-Rosich, Head of Section of the Neurology Department at Vall d'Hebron University Hospital in Barcelona and principal investigator in the SUNRISE trial, noted: "The SUNRISE trial marks a significant step forward in the mission to make migraine-specific preventive treatments more globally accessible, ensuring that patients with severe migraine receive the care they need."
Based on the SUNRISE results, Lundbeck has initiated discussions with relevant regulatory authorities with the aim of making eptinezumab available for people suffering from migraine across Asia.
About Eptinezumab
Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and was intentionally designed for intravenous administration. The drug was approved by the U.S. FDA for preventive treatment of migraine in adults in February 2020 and received European Commission marketing authorization in January 2022. Today, eptinezumab is launched in more than 30 markets worldwide.
The safety of eptinezumab has been evaluated in more than 2,000 adult patients with migraine. In previous PROMISE-1 and PROMISE-2 trials, only 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions.
