Benzinga | Nov 18, 2021 08:04AM EST

Eli Lilly Reports Enrollment Of Patients In Emgality Versus Nurtec Head-To-Head Migraine Treatment Study

- CHALLENGE-MIG is the first and only clinical trial comparing two anti-calcitonin gene-related peptide (CGRP) medicines, Emgality and Nurtec ODT, which work differently

- The study's primary endpoint is the percentage of patients with ?50% reduction from baseline in monthly migraine headache days

- The study's secondary endpoints include quality of life improvements and the percentage of patients with ?75% and 100% reductions from baseline in monthly migraine headache days

INDIANAPOLIS, Nov. 18, 2021 /PRNewswire/ -- Today, Eli Lilly and Company (NYSE:LLY) announced that enrollment is now open for the CHALLENGE-MIG clinical trial, the first and only head-to-head trial comparing two anti-calcitonin gene-related peptide (CGRP) medicines for the preventive treatment of episodic migraine in adults.1 The study is evaluating once-monthly Emgality(r) (galcanezumab-gnlm) injection compared to Nurtec(r) ODT (rimegepant), a tablet patients take every other day, on patient-centric measures, including reductions in monthly migraine headache days and quality of life improvement.

While Nurtec ODT and Emgality are both medications that target CGRP, because Emgality is a monoclonal antibody (mAb) that binds to CGRP (a protein found in the brain thought to play a key role in migraine), it works differently than gepants like Nurtec ODT, that bind to and block the CGRP receptor.2-4 Emgality is the only CGRP medication with ?50%, ?75% and 100% reductions of monthly migraine headache days in its label for people with episodic migraine experiencing 4 to 14 migraine headache days per month. Lilly's CHALLENGE-MIG study aims to deepen the understanding of CGRP monoclonal antibodies (mAbs) compared to oral gepants in the preventive treatment of migraine and answer important questions that will help physicians and patients make informed treatment decisions.

"Migraine can greatly impact day-to-day activities, robbing people of their routines and their everyday and special occasions in life. Reducing the frequency of migraine attacks can help people achieve more migraine-free days and enjoy an improved quality of life; both of which are essential treatment goals," said Shivang Joshi, a trial investigator and neurologist at Dent Neurologic Institute. "Lilly's CHALLENGE-MIG study will help us understand how different types of preventive medications (CGRP mAbs vs. gepants) may help people achieve the goals that matter most to them. It's exciting that insights generated in this first-of-its-kind head-to-head trial will be able to spark treatment plan discussions between people with migraine and their health care providers."

The CHALLENGE-MIG clinical trial is expected to enroll approximately 700 adults across the U.S. with episodic migraine, and individual participation in the study can last up to 6 months. For more information about the CHALLENGE-MIG trial, contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979). Information about the CHALLENGE-MIG study is also available at the Lilly booth at the American Headache Society's annual education symposium taking place in Scottsdale, AZ, November 18-21, 2021.

"Lilly has been deeply committed to neuroscience research across a spectrum of diseases for over 30 years," said Anne White, senior vice president of Eli Lilly and Company and president of Lilly Neuroscience. "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."