Eptinezumab (Alder BioPharmaceuticals), an investigational treatment for migraine prevention, has met its pivotal Phase 3 trial primary endpoint of significant reduction in monthly migraine days versus placebo.
Eptinezumab is a monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP), which is believed to play a key role in mediating and initiating migraine. If approved it would become the first-to-market infusion therapy for migraine prevention.
The PROMISE 2 study included 1,072 patients who were randomized to receive eptinezumab (300mg or 100mg), or placebo once every 12 weeks. Results showed that the treatment group had a monthly migraine day reduction of 8.2 compared to 5.6 in the placebo group (P <.0001).
Beginning Day 1 post-infusion, a 52% reduction in migraine risk was seen in the eptinezumab group compared to 25% in the placebo group (P <.0001). “Rapid onset of effect is a true paradigm shift in migraine preventive treatment,” said Peter Goadsby, MD, PhD, DSc, neurologist at the University of California, San Francisco Medical Center. “I’m excited about the potential for my patients to experience early and meaningful periods of migraine freedom if new treatments become approved.”
Adverse events were similar in both the treatment and placebo group. The most commonly reported adverse events for eptinezumab were nasopharyngitis (6.3%), upper respiratory infection (4%), nausea (3.4%) and urinary tract infection (3.1%).
The Company plans to submit a Biologics License Application to the Food and Drug Administration (FDA) in the second half of 2018.
Alder Announces Eptinezumab Significantly Reduces Migraine Risk Meets Primary and All Key Secondary Endpoints in Pivotal PROMISE 2 Phase 3 Trial for Chronic Migraine Prevention [news release]. Bothell, WA: Alder Biopharmaceuticals. January 8, 2018.
This article originally appeared on MPR