Eli Lilly and Company has commenced subject enrolment in Phase IV CHALLENGE-MIG clinical trial Emgality (galcanezumab-gnlm) injection as a preventive therapy for episodic migraine in adult patients.
A monoclonal antibody, Emgality specifically attaches to calcitonin gene-related peptide (CGRP).
The drug is approved by the US Food and Drug Administration (FDA) as preventive migraine therapy for adults.
In June 2021, the company announced plans to study Emgality against oral Nurtec ODT in a Phase IV head-to-head study as a preventive migraine treatment.
This double-blind, randomised, placebo-controlled trial will compare the efficacy and safety of a once-monthly injectable dose of Emgality to oral doses of Nurtec ODT (rimegepant) given on alternative days.
It will enrol nearly 700 adult subjects across the US who will be analysed for a duration of up to six months.
CHALLENGE-MIG is claimed to be the first-ever trial to compare two CGRP therapies as episodic migraine prevention treatment.
The percentage of subjects with a reduction of ≥50% in monthly migraine headache days from baseline throughout the three-month double-blind treatment duration will be the trial’s primary goal.
A ≥75% decline and complete reduction from baseline in monthly migraine headache days, advances in the migraine-specific quality of life, and migraine disability assessment will be the secondary goals of the trial.
Eli Lilly and Company senior vice-president Anne White said: “Lilly has been deeply committed to neuroscience research across a spectrum of diseases for over 30 years.
“We believe patients should expect more and get more from medications that can help prevent migraine. Therefore, we look forward to sharing the findings from our Emgality versus Nurtec ODT head-to-head trial.”
In June 2019, the FDA approved Emgality for the treatment of episodic cluster headache in adults