Lundbeck’s humanised monoclonal antibody, Vyepti (eptinezumab), has met both primary and secondary endpoints in the placebo-controlled, randomised Phase IV RESOLUTION trial in patients with chronic migraine and associated medication-overuse headache (MOH), who also obtained standardised patient education.
The trial involved 608 subjects diagnosed with both chronic migraine and MOH. They were randomly assigned to receive either eptinezumab, with a brief educational intervention (BEI), or a placebo and BEI.
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The primary goal was to assess the change in the number of monthly migraine days (MMDs) from baseline over the first four weeks.
RESOLUTION demonstrated an average decrease of 6.9 days from baseline in the number of MMDs while the placebo group saw a reduction of 3.7 days.
Other secondary and exploratory goals evaluated MMDs over weeks one to 12, the transition from chronic to episodic migraine, MOH remission, decrease in headache-related burden, migraine-related disability, activity impairment, loss of work productivity, and the antibody’s tolerability and safety.
In addition, acute migraine medication usage was found to be decreased by more than half with eptinezumab treatment.
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By GlobalDataOver 12 weeks, subjects receiving the antibody reduced their reliance on acute treatment by 11.2 days per month, versus a 7.8-day decrease for those receiving the placebo.
The trial also observed a decrease in daily pain severity from as early as week two, with the antibody showing a change in baseline on the daily pain assessment score of -0.6, against -0.3 with the placebo.
Lundbeck Research and Development head and executive vice-president Johan Luthman said: “We see robust benefits with eptinezumab, even on top of existing patient education. These results highlight Lundbeck’s dedication to raising the bar in migraine treatment expectations, ensuring that even the most difficult-to-treat patients have access to effective solutions.”
According to the company, the antibody attaches to calcitonin gene-related peptides (CGRP) and is specifically designed for intravenous administration.
Last year, Lundbeck commenced the PROCEED Phase IIb trial to assess the efficacy and safety of Lu AG09222 for migraine prevention.
