Lundbeck has announced positive results from the Phase III SUNRISE trial, evaluating Vyepti (eptinezumab) for migraine prevention in patients with chronic migraine, predominantly in Asia. The trial met its primary endpoint, demonstrating statistically significant reductions in mean monthly migraine days (MMD) compared to placebo. These findings support Vyepti's potential as an effective preventive treatment option for migraine in this population.
Key Findings from the SUNRISE Trial
The SUNRISE trial (NCT04921384) was a multi-regional, randomized, double-blind, placebo-controlled study involving 983 participants with chronic migraine, defined as migraine occurring on ≥8 days per month and headache occurring on >14 days. Participants were randomized to receive Vyepti 100 mg, Vyepti 300 mg, or placebo via intravenous infusion.
From a baseline average of 17 migraine days, patients treated with Vyepti experienced significant reductions in MMDs over weeks 1-12. The mean reductions were -7.5 days for the 300 mg group and -7.2 days for the 100 mg group, compared to -4.8 days for the placebo group (p<0.0001 for both Vyepti doses vs. placebo). Furthermore, a significantly greater proportion of patients achieved ≥50% reduction in MMDs with both Vyepti doses compared to placebo.
The trial also confirmed the early onset of preventive effects, with a significantly lower proportion of patients experiencing migraine on the day following infusion with Vyepti compared to placebo. Vyepti also demonstrated that more patients achieved ≥75% reduction in MMDs compared to placebo.
Safety and Tolerability
The safety profile of Vyepti in the SUNRISE trial was generally similar to placebo. The most common treatment-emergent adverse events (TEAEs) were COVID-19 and nasopharyngitis. These rates were consistent with those reported in previous Vyepti trials.
Clinical Significance and Market Potential
"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."
Migraine is a prevalent neurological disorder with a substantial impact on individuals' lives and productivity. In China, an estimated 14.3% of adults are living with migraine, with a significant portion seeking hospital care but only a fraction receiving a proper diagnosis. The SUNRISE trial results pave the way for Lundbeck to engage with regulatory authorities to potentially expand Vyepti's availability to address this unmet need in Asia.
About Vyepti (Eptinezumab)
Vyepti is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a key mediator in migraine pathophysiology. It is administered intravenously and has demonstrated efficacy in both episodic and chronic migraine in previous Phase III trials (PROMISE-1 and PROMISE-2). Vyepti is currently approved in the United States and the European Union for the preventive treatment of migraine in adults.
