Last week, Eli Lilly and Company (“Lilly”) announced that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headaches. Lilly previously announced that galcanezumab met its primary endpoints in three different Phase 3 studies evaluating its effectiveness in preventing episodic and chronic migraine.

The episodic cluster headache study was a two-month Phase 3, randomized, double-blind, placebo-controlled, global trial evaluating the safety and efficacy of galcanezumab (300 mg once-monthly) administered subcutaneously compared with placebo in 106 patients.  According to Lilly, patients treated with galcanezumab experienced statistically significant differences in the reduction of weekly cluster headache attacks compared to patients treated with placebo across weeks one to three of the study.  The safety and tolerability profile was consistent with previous studies evaluating galcanezumab for the prevention of migraine.

Galcanezumab is a monoclonal antibody that is designed to bind to and inhibit the activity of calcitonin gene-related peptide (“CGRP”).  Increased levels of CGRP have been reported in patients during migraine and cluster headache episodes.  Based on the results of the migraine Phase 3 trials, Lilly submitted galcanezumab to the FDA for review, and a decision is expected in the third quarter of this year.  Based on the results of the cluster headache trial, Lilly will no doubt seek to add the treatment of episodic cluster headaches as an indication for galcanezumab.

CGRP antagonists such as galcanezumab have been a focus for a number of companies seeking to develop migraine treatments.  In addition to Lilly’s galcanezumab, two other anti-CGRP antibodies are in late-stage development.  In fact, Teva has already submitted an application for its fremanezumab to the FDA (although manufacturing concerns have delayed FDA approval until at least September), and Alder Biopharmaceuticals is expected to submit an application for its eptinezumab later this year.  In addition, as we previously reported, Amgen and Novartis recently announced that the FDA approved its Aimovig™ (erenumab) product for the preventive treatment of migraine, although erenumab targets the CGRP-receptor instead of CGRP itself.