A Phase 2b clinical trial of eptinezumab (Alder Biopharmaceuticals) has found that a single administration of the intravenous treatment led to a clinically meaningful reduction in the percentage of patients experiencing migraines within 24 to 48 hours.
Eptinezumab, formerly known as ‘ALD403′, is anti-CGRP (calcitonin gene-related peptide) antibody. A total of 616 migraine patients were enrolled in the Phase 2b trial across 90 sites. They were randomized to receive either 10mg, 30mg, 100mg or 300mg of eptinezumab, or a placebo.
Results met the primary endpoint of a significant reduction in migraine days for the eptinezumab groups, as measured by 75% responder rates. Maximum efficacy was noted in 1 to 4 weeks and sustained through 12 weeks for one-third of those enrolled.
“The data from these trials, and the fact that it’s the only anti-CGRP monoclonal antibody being developed for administration via infusion, suggest that, if approved, eptinezumab may be an important therapeutic option for patients needing fast onset to migraine prevention,” said Jeffrey Smith, MD, FRCP, a founder of Alder and managing director of Alder’s Irish subsidiary, Alder BioPharmaceuticals Limited.
Regarding next steps, Alder CEO, Randall C. Schatzman, PhD, said, “We are on track to report top-line results from our first Phase 3 pivotal trial of eptinezumab later this quarter. Our focus is on moving through the clinical development program toward a BLA filing next year.”
For more information visit Alderbio.com.