Eptinezumab Reduces Migraines Over Long-Term PROMISE 1 Results

Stephen D. Silberstein, MD

New 12-month data from a phase 3 trial testing the efficacy of eptinezumab for the prevention of migraines has shown the calcitonin gene-related peptide (CGRP)-targeting therapy is capable of reducing migraines at 2 different doses.

The results from Alder Biopharmaceutical’s Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy 1 (PROMISE 1) clinical study demonstrated reductions in migraine following study third and fourth quarterly infusions of both 100 mg and 300 mg eptinezumab versus placebo in patients with episodic migraines. PROMISE 1 also reported a comparable safety profile to that of previous trials involving eptinezumab.

The news bodes well for eptinezumab, as Alder hopes to have it approved by the US Food and Drug Administration (FDA) as the first migraine infusion therapy.

The original double-blind, placebo-controlled global trial randomized 888 qualified patients to receive either eptinezumab (300 mg, 100 mg, or 30 mg), or placebo infusion, once-weekly for 12 weeks. All patients had previously experienced at least 14 headache days per month, with 4 of such headaches meeting the criteria for migraine.

Primary endpoint for the trial was mean change from baseline in monthly migraine days over the treatment period. Results presented at the AAN meeting focused on the therapy’s extended results through month 12.

For the long-term analysis, patients were dosed once every 3 months. Through months 6-12, 70.7% of patients to receive eptinezumab reported an average reduction of 50% or greater of monthly migraine days from baseline, compared to just 58.7% for patients given placebo. The reduction was an 8.9% improvement from mean reductions reported during the first 2 quarterly doses of therapy.

Another 51.5% of eptinezumab patients reached a mean monthly migraine day reduction of 75% or greater from baseline. Just 38.7% of patients given placebo reported that rate. This reduction was 12.*% improvement on that reduction rate reported by patients given therapy in the first 2 quarterly doses.

From its safety profile, the most commonly reported adverse events in all eptinezumab treatment groups were upper respiratory infection (10.5%), nasopharyngitis (6.8%) and sinusitis (3.6%).

Stephen D. Silberstein, MD, professor of Neurology and director of the Jefferson Headache Center at Thomas Jefferson University, said in a statement that it is exciting to see such encouraging results in investigative migraine prevention therapy.

“I see a significant need for my patients for a treatment that provides rapid, effective, well-tolerated and long-term results and I’m looking forward to the FDA’s review of these data,” Silberstein.

Eptinezumab is also backed by another phase 3 trial (PROMISE 2), in which 1072 patients were randomized to receive either eptinezumab (300 mg or 100 mg) or placebo.

In January, Alder reported that therapy again met its primary endpoint of mean change from baseline in monthly migraine days over the 12 week treatment period. It also met secondary endpoints of reduction in migraine prevalence day 1 and days 1-28; reduction in mean monthly migraine days of at least 50%, 75%, and 100% from baseline; change from baseline in mean monthly acute migraine-specific medication days; and reductions from baseline in patient-reported impact scores on the Headache Impact.

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