Eli Lilly announced positive results from a Phase 3 trial which investigated galcanezumab in the treatment of episodic cluster headaches. Galcanezumab, an investigational once-monthly, self-administered injection, is a monoclonal antibody designed to bind and inhibit the activity of calcitonin gene-related peptide (CGRP).
The episodic cluster headache trial included a total of 106 patients with an average of 17.5 cluster headache attacks per week at baseline. Patients were randomized to either once-monthly galcanezumab 300mg administered subcutaneously or placebo.
Results showed that across Weeks 1 to 3 of the 2-month study period, the galcanezumab group saw a statistically significant difference in the reduction of weekly cluster headache attacks compared with placebo (primary endpoint) (-8.7 for galcanezumab vs -5.2 for placebo; P=.036). With regard to the secondary endpoint, a statistically significantly greater percentage of patients in the galcanezumab group achieved ≥50% reduction in weekly cluster headache attacks compared with placebo at Week 3.
Safety findings were consistent with previous studies of galcanezumab. Eight percent of the treatment group and 21% of the placebo group discontinued treatment during the study.
The Food and Drug Administration (FDA) is currently reviewing galcanezumab for the prevention of migraines in adults with a decision expected in the third quarter of 2018.
For more information visit Lilly.com.