Source: Eli Lilly and Company
On June 16, 2023, Eli Lilly and Company released the findings of the CHALLENGE-MIG clinical trial, which evaluated the effectiveness of Emgality (galcanezumab-gnlm) and NurtecĀ® ODT (rimegepant orally disintegrating tablet), the first trial of its kind comparing two therapies targeting calcitonin gene-related peptide (CGRP) antagonists. Although Emgality did not achieve the primary objective of the study, which was to demonstrate statistical superiority over Nurtec ODT in the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days, both treatments showed similar response rates. However, Emgality exhibited clinically significant efficacy and safety throughout the 3-month study, aligning with its previous 6-month studies. Additionally, Emgality demonstrated better performance on important secondary endpoints compared to Nurtec ODT in the 3-month trial.
“These results bolster our knowledge of Emgality’s ability to work quickly and help patients improve their quality of life with less frequent dosing. Reducing the frequency of migraine headache days can help people experience more freedom from the burden of this debilitating neurological disease and get back to participating in the daily activities that matter most to them.”
– Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience
The CHALLENGE-MIG clinical trial was a double-blind study conducted over a 3-month period, involving 580 adult participants with episodic migraines. The primary objective of the study was to compare the efficacy and safety of Emgality and Nurtec ODT in preventing these migraines. The participants were randomly assigned to receive either four injections of Emgality 120 mg (a loading dose of two injections followed by two additional monthly injections) or 45 doses of Nurtec ODT 75 mg (one oral tablet every other day), which are the approved doses recommended by regulatory authorities. To maintain blinding, patients receiving Emgality also received placebo oral tablets, while patients receiving Nurtec ODT were administered placebo injections. It is important to note that Emgality is a monoclonal antibody that directly binds to CGRP, inhibiting its effects, whereas Nurtec ODT is a gepant that blocks the CGRP receptor.
“Despite being the third most common disease worldwide, migraine remains largely under-diagnosed and under-treated. I applaud Lilly for embarking on this bold study and their continued investment in the migraine community to better inform care. These results reinforce the impact that innovative medicines can have in the prevention of migraine.”
– Peter Goadsby, MBBS, M.D., Ph.D., King’s College London and University of California, Los Angeles, CA.
During the CHALLENGE-MIG trial, the safety profiles of Emgality and Nurtec ODT were in line with the previously reported data for both treatments. No new safety concerns were identified. The company plans to release the complete findings of the CHALLENGE-MIG trial later this year, providing a comprehensive overview of the results.
