Eptinezumab for frequent episodic migraine (EM) met primary and key secondary endpoints in the PROMISE 1 phase 3 trial.
The pivotal PROMISE 1 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) phase 3 trial has shown that eptinezumab for frequent episodic migraine (EM) met primary endpoints, as well as key secondary endpoints, with benefits beginning on day 1 after the first dose.
Among the key findings, the study, which enrolled 888 patients, showed that an average of 1 in 5 patients experienced no migraine days per month (MDD) in any month from 1 to 6. From an average of 8.6 MMD at baseline, the primary endpoint of statistically significant reductions in MMD was met over week 1 through week 12, with a 4.3-day reduction for the 300-mg dose (P = .0001) and a 3.9-day reduction for the 100-mg dose (P = .0179) compared with an average 3.2-day reduction for placebo.
Among the secondary endpoints met in PROMISE 1 were a ≥75% reduction in MMD over week 1 through week 4 of 31.5% for the 300-mg dose (P = .0066) and 30.8% for the 100-mg dose (P = .0112), compared with 20.3% for placebo. Also met was a ≥50% reduction in MMD that was achieved by 56.3% of the patients over week 1 through week 12 for the 300-mg dose (P = .001) and 49.8% for the 100-mg dose (P = .0085, unadjusted), compared with 37.4% for placebo. In week 13 through week 24, there was a ≥75% reduction in MMD of 40.1% for the 300-mg dose (P = .0006, unadjusted), and 33.5% for the 100-mg dose (P = .0434, unadjusted) compared to 24.8% for the placebo group.
"Approximately 13 million people suffer from the pain and debilitation of migraines that occur 4 or more days a month, yet 9 out of 10 individuals don't utilize preventive therapy due to limitations in efficacy, safety, and tolerability," said Roger Cady, MD, Alder’s vice president of neurology and a Fellow in the American Headache Society. "Patients deserve more from their treatments, and these data show eptinezumab could be a major advance in meeting the significant unmet need for patients to regain control of their lives."
PROMISE also showed a 53.6% reduction in the proportion of patients who experienced a migraine on the day after administration of eptinezumab 300 mg (P = .0087, unadjusted), and 51.3% at the 100-mg dose (P = .0167, unadjusted), compared with 20.7% for the patients in the placebo group.
While full safety data will be available at the conclusion of the study, to date the safety profile is similar to placebo, and are consistent with previous study results reported for eptinezumab.
"These positive results, consistent with previously reported eptinezumab studies, support the unique clinical profile of eptinezumab as a potential first-of-its-kind infusion therapy to prevent migraines,” Randy Schwartzman, PhD, Alder’s president and chief executive officer, said in a news release announcing the results.
Alder is now turning its sights on enrollment for PROMISE 2, a second pivotal phase 3 study that will investigate eptinezumab’s effects on CM. The results of both studies as well as an open-label safety study will comprise Alder’s submission for its Biologics License Application with the FDA in the second half of 2018.