Monoclonal antibody tops placebo for reducing migraine frequency

The humanized monoclonal antibody directed against the pituitary adenylate cyclase-activating polypeptide (PACAP) ligand, Lu AG09222, is better than placebo for reducing migraine frequency over four weeks, according to a study published in the Sept. 5 issue of the New England Journal of Medicine.

Messoud Ashina, M.D., from Copenhagen University Hospital in Denmark, and colleagues conducted a Phase II, double-blind trial involving adults with migraine for whom two to four previous preventive treatments had failed to provide a benefit.

The trial included a four-week treatment period and an eight-week follow-up period. Participants were randomly assigned to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo (97, 46, and 94 individuals, respectively).

The researchers found that in the overall population, the mean number of migraine days per month was 16.7, and the mean change from baseline over weeks one through four was −6.2 and −4.2 days in the Lu AG09222 750-mg group and placebo group, respectively (difference, −2.0 days).

During the 12-week observation period, adverse events with a higher incidence in the Lu AG09222 750-mg group versus the placebo group included COVID-19 (7 versus 3 percent), nasopharyngitis (7 versus 4 percent), and fatigue (5 versus 1 percent).

"This finding establishes proof of concept, supporting the notion that inhibition of PACAP signaling by Lu AG09222 represents a potentially effective mechanism for migraine prevention," the authors write.

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