Lundbeck has announced positive results from the Phase III SUNRISE trial of Vyepti (eptinezumab) in patients with chronic migraine, predominantly conducted in Asia. The trial met its primary endpoint, demonstrating statistically significant reductions in mean monthly migraine days (MMD) compared to placebo.
The SUNRISE trial (NCT04921384) was a multi-regional, multi-site, randomized, double-blind, placebo-controlled study designed to confirm the efficacy and safety of Vyepti in participants with chronic migraine eligible for preventive treatment. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days. The trial randomized 983 participants to receive Vyepti 100 mg, Vyepti 300 mg, or placebo via intravenous (IV) infusion.
Efficacy Results
From a baseline of approximately 17 days, patients treated with Vyepti experienced significant reductions in MMDs over weeks 1 through 12. The 300 mg group saw a reduction of -7.5 days, and the 100 mg group saw a reduction of -7.2 days, 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 monthly migraine days over weeks 1-12 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.
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. The rates of TEAEs with Vyepti were consistent with previously reported trials.
Addressing Unmet Needs in Asia
"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."
Vyepti's Mechanism and Prior Studies
Vyepti (eptinezumab) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), specifically developed for IV administration. Its efficacy and safety were previously demonstrated in the PROMISE-1 trial (episodic migraine) and PROMISE-2 trial (chronic migraine), where it met the primary endpoint of decreasing mean monthly migraine days over weeks 1-12 in both episodic and chronic migraine. These trials also showed a treatment benefit over placebo as early as day 1 post-infusion.
Next Steps
Based on the SUNRISE trial results, Lundbeck plans to initiate discussions with relevant regulatory authorities to make Vyepti available for people suffering from migraine across Asia.
