Eli Lilly is planning to conduct a head-to-head study comparing its calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) Emgality with Biohaven Pharmaceuticals’ Nurtec for the preventative treatment of migraine.
The study will directly compare once-monthly Emgality (galcanezumab) to Nurtect ODT (rimegepant), which is administered as an orally disintegrating tablet taken every other day.
It will enrol patients who meet the International Classification of Headache Disorders (ICHD) criteria for a diagnosis of episodic migraine, with or without aura.
Patients will be randomised to one of two treatment arms – Emgality 120mg once-monthly injection with an initial 240mg loading dose and Nurtec ODT 75mg taken every other day.
The primary endpoint of the study is a 50% reduction in monthly migraine headache days, with enrolment set to begin later this year.
"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," said Ilya Yuffa, senior vice president and president, Lilly Bio-Medicines.
"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,” he added.
While Emgality works to block the CGRP protein – believed to play a key role in migraine – Nurtec ODT works to block the receptor for this protein.
The aim of the study is to answer ‘important questions’ to aid patients and clinicians in making more informed treatment decision relating to migraine treatment, Lilly said in a statement.