Lundbeck announces positive results from phase III pivotal trial (SUNRISE) of Vyepti (eptinezumab) in migraine prevention

Lundbeck announced that Vyepti (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III pivotal trial predominantly conducted in Asia evaluating the efficacy and safety in patients with chronic migraine. SUNRISE (NCT04921384) was 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 were eligible for preventive treatment- that started in May 2021. 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 wias followed by an extension period where all participants received 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 was approximately 36 weeks and included 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)..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. 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.