H. Lundbeck A/S announced positive results from the SUNRISE phase III clinical trial of Vyepti (eptinezumab) in patients with chronic migraine, predominantly conducted in Asia. The trial met its primary and all key secondary endpoints, paving the way for potential regulatory submissions in Asia.
The SUNRISE trial evaluated the efficacy and safety of Vyepti in patients with chronic migraine. The primary endpoint was the change from baseline in monthly migraine days (MMD) over weeks 1 through 12. Key secondary endpoints included the proportion of patients achieving at least a 50% reduction in MMDs.
Efficacy Results
The trial demonstrated statistically significant reductions in MMDs compared to placebo. Specifically, patients treated with 300 mg of Vyepti experienced a mean reduction of 7.5 MMDs from a baseline average of 17 days, while those treated with 100 mg experienced a reduction of 7.2 MMDs. In comparison, the placebo group experienced a reduction of 4.8 days (p<0.0001 for both Vyepti doses vs. placebo).
Furthermore, a significantly greater proportion of patients treated with Vyepti achieved at least a 50% reduction in MMDs 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 Profile
The observed 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.
Based on these results, Lundbeck plans to initiate discussions with relevant regulatory authorities to potentially make Vyepti available for migraine sufferers across Asia.
