An investigational treatment for the prevention of episodic and chronic migraine has met its primary endpoint in three phase 3 studies.
Eli Lilly and Company’s galcanezumab demonstrated significant reductions in the number of monthly migraine headache days compared to placebo. Galcanezumab is a monoclonal antibody designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP), which is believed to play a role in migraine and cluster headaches. Galcanezumab is a self-administered subcutaneous injection dosed at 120 mg or 240 mg once-monthly following a 240-mg starting dose.
“Though there are a number of prescription treatments used to treat the symptoms of migraine, CGRP antibodies—if approved by the FDA—will be the first class of drugs specifically designed for the prevention of migraine,” said Eric Pearlman, M.D., Lilly medical fellow and the medical lead in the United States for galcanezumab. “We hope and believe that the advent of the CGRP class will substantially improve care for these patients.”
The studies that evaluated the use of galcanezumab in chronic and episodic migraine are EVOLVE-1, EVOLVE-2 and REGAIN, all of which were randomized, double-blind and placebo-controlled global trials.
In both EVOLVE-1 and EVOLVE-2, patients with episodic migraine were treated over a 6-month period with either galcanezumab 120 mg or 240 mg doses. These patients had an average of 9.1 migraine headache days per month at baseline. Both groups of patients experienced a significantly greater decrease in the average number of monthly migraine headache days compared to those treated with placebo. In EVOLVE-1, the average reduction in monthly migraine days was 4.7 days for 120 mg and 4.6 days for 240 mg compared to an average 2.8-day reduction for placebo. In EVOLVE-2, the average reduction was 4.3 days for 120 mg and 4.2 days for 240 mg compared to 2.3 days for placebo.
In REGAIN, patients with chronic migraine were treated over a three month period with galcanezumab 120 mg or 240 mg doses. These patients had an average of 19.4 migraine headache days per month at baseline. Again, both groups experienced a significantly greater decrease in the average number of monthly migraine headache days compared to placebo. The average reduction was 4.8 days for 120 mg and 4.6 days for 240 mg compared to an average reduction of 2.7 days for placebo.
In all 3 trials, patients treated with galcanezumab also experienced statistically significant improvement compared to placebo in secondary endpoints, including response rates and measures of daily activities. The most common adverse events associated with the use of galcanezumab in the studies were injection site reactions, including pain.
“The topline results from these studies reaffirm the potential for galcanezumab to provide a new treatment option for migraine,” said Pearlman. “More importantly, they bring use one step closer to helping people experience more migraine-free days per month, an important treatment foal for those living with this disease.”
Based on the results of the studies, Lilly will submit a Biologics License Application to FDA for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.