Emgality will be evaluated as a once-monthly injectable. Credit: Markus Spiske on Unsplash.

Eli Lilly has plans to compare once-monthly injectable Emgality (galcanezumab-gnlm) in a Phase IV head-to-head study with every-other-day oral Nurtec ODT (rimegepant) as a preventive treatment for migraine.

Emgality attaches to the calcitonin gene-related peptide (CGRP) protein, which is linked to migraine and prevents its binding to the CGRP receptors. Meanwhile, Nurtec ODT inhibits the receptor for CGRP.

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The multi-site, randomised, double-blind, double-dummy, parallel-group head-to-head study will assess a 120mg once-monthly injection of Emgality, with a 240mg loading dose, compared to 75mg every-other-day Nurtec ODT.

With enrolment set to start in the coming months, the Phase IV study will involve patients meeting the International Classification of Headache Disorders (ICHD) criteria for episodic migraine with or without aura.

The study is the first of its kind to compare two CGRP-targeting medicines. It is expected to provide data that could aid informed treatment decisions focused on more migraine-free days.

A 50% decrease in monthly migraine headache days will be the study’s primary endpoint.

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Eli Lilly Bio-Medicines senior vice-president and president Ilya Yuffa said: “Migraine is a painful, burdensome and complex neurologic disease. Every person’s experience is different. Providing patients with options and individualised treatment plans is vitally important.

“We are confident in Emgality’s efficacy profile and that our head-to-head clinical trial against Nurtec ODT will yield valuable insights for patients and their healthcare providers.”

Emgality is the only CGRP medicine with ≥50%, ≥75% and 100% decrease in monthly migraine headache days for the episodic migraine treatment period, included in its US Food and Drug Administration (FDA)-approved labelling.

The drug received the FDA approval for the preventive migraine treatment in adults in September 2018 and to treat episodic cluster headache in June 2019.

In December 2019, Lilly launched a real-world evidence study, named TRIUMPH, to compare Emgality to other migraine preventive treatments.

The study was designed to assess the long-term effectiveness of Lilly’s drug in individuals on routine medical care who are switching to a new migraine prevention therapy.