N Engl J Med

Novel antibody shows promise for migraine prevention

September 9, 2024

A single IV infusion of the humanized monoclonal anti-PACAP antibody Lu AG09222 was superior to placebo for reducing migraine frequency over 4 weeks.

• The phase 2 HOPE trial enrolled 237 adults (18-65 years) with migraine who’d failed two to four previous preventive treatments. The trial included a 4-week treatment period and an 8-week follow-up period. Participants were randomly assigned to receive a single-dose baseline infusion of 750 mg of Lu AG09222 (n=97), 100 mg of Lu AG09222 (n=46), or placebo (n=94). Primary end point was mean change from baseline in number of migraine days per month, during weeks 1 through 4, in the Lu AG09222 750-mg group vs. the placebo group.
• Mean number of baseline migraine days per month was 16.7 in the overall population. Mean change from baseline over weeks 1 through 4 was -6.2 days in the Lu AG09222 750-mg group, vs. -4.2 days in the placebo group. During the 12-week observation period, adverse events with a higher incidence in the Lu AG09222 750-mg group vs. the placebo group included COVID-19 (7% vs. 3%), nasopharyngitis (7% vs. 4%), and fatigue (5% vs. 1%).

Source:

Ashina M, et al. (2024, September 8). N Engl J Med. A Monoclonal Antibody to PACAP for Migraine Prevention. https://pubmed.ncbi.nlm.nih.gov/39231342/