Galcanezumab met its primary endpoint in a Phase III study of patients with episodic cluster headache.- Eli Lilly.

Eli Lilly and Company announced that galcanezumab met its primary endpoint in a Phase III study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. A statistically significantly greater percentage of patients treated with galcanezumab also achieved at least a 50 percent reduction in weekly cluster headache attacks compared to placebo at Week 3, the gated secondary endpoint.

The observed safety and tolerability profile was consistent with previous studies that evaluated galcanezumab for the prevention of migraine. In this study, 8 percent of patients treated with galcanezumab discontinued treatment during the study compared to 21 percent of patients treated with placebo. Four percent of patients treated with galcanezumab discontinued treatment during the study due to adverse events compared to 2 percent of patients treated with placebo. Discontinuations due to lack of efficacy occurred in 2 percent of patients treated with galcanezumab, compared to 14 percent of patients treated with placebo.

Lilly also conducted a separate Phase III study for patients with chronic cluster headache, which represents 10 to 15 percent of cluster headache cases. This study did not meet its primary endpoint. Based on results from the episodic cluster headache trial, Lilly is working with regulatory agencies around the world to determine the best path forward. Episodic cluster headache represents 85 to 90 percent of cluster headache cases.