Lilly’s anti-CGRP Galcanezumab Hits the Mark in Phase III Cluster Headache Study

Eli Lilly and Company continues to see positive news in its efforts to combat migraine headaches. This morning Lilly revealed Phase III results that show its anti-CGRP galcanezumab achieved statistically significant differences in the reduction of weekly cluster headache attacks.

In a two-month study data showed that galcanezumab was able to reduce weekly cluster headaches within the first three weeks. The late-stage study also showed patients treated with galcanezumab achieved at least a 50 percent reduction in weekly cluster headache attacks compared to the placebo by the third week of treatment. Patients who participated in this trial had an average of 17.5 cluster headache attacks per week at baseline, Eli Lilly said.

A cluster headache is composed of recurrent "attacks" of intense headaches on one side of the head, frequently associated with pain behind or around one eye, restlessness and agitation. The pain from cluster headaches can be disabling. They can typically last between 15 minutes and three hours. Cluster headaches are often considered “episodic,” which means attacks occur frequently for a short time before going into remission for one month or longer.

Galcanezumab, a non-opioid pain treatment, is a once-monthly, self-administered monoclonal antibody specifically designed to bind to and reduce the over-activity of calcitonin gene-related peptide (CGRP). The peptide is believed to play a role in migraine and cluster headaches.

"Cluster headache can be difficult to evaluate in clinical studies, which has contributed to few available treatment options for cluster headache, often considered the most severe pain one can experience," Christi Shaw, president of Lilly Bio-Medicines, said in a statement. "The positive results in episodic cluster headache are truly a landmark moment—both for people living with cluster headache and for our researchers at Lilly, many of whom have spent more than two decades researching and developing innovative, non-opioid treatment options for diseases like migraine and cluster headache.”

With positive results in hand, Eli Lilly said it will begin discussions with regulatory agencies to seek approval for galcanezumab in the treatment of cluster headaches. The U.S. Food and Drug Administration is currently reviewing galcanezumab for the prevention of migraine headaches in adults. A decision for that is expected in the third quarter of this year.

In April, at the American Academy of Neurology meeting in Los Angeles, Eli Lily also presented data that shows galcanezumab reduces monthly migraine headache days in patients who have previously failed to respond to multiple therapies. Lilly presented data that showed galcanezumab generated a significant reduction in the average number of monthly migraine headache days in the patient population. Depending on dosing levels Lilly said its medication cut the average number of monthly migraine days by 3.45 days for 120 mg and 3.85 days for 240 mg.

While Lilly’s galcanezumab has generated positive data across multiple late-stage trials, the company noted that the drug missed the mark in one Phase III study – for chronic cluster headaches. Patients with that type of headache represent 10 to 15 percent of cluster headache cases. The trial failed to meet its primary endpoint, Lilly said.

Eli Lilly did note that in the cluster headache trial that 4 percent of patients treated with galcanezumab discontinued treatment 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, the company added.