New Phase 3 data suggest that Eli Lilly’s investigational monoclonal antibody galcanezumab may significantly reduce the number of monthly migraine headache days. In the EVOLVE-1 study, patients with episodic migraine treated with galcanezumab 120 mg over a six-month period experienced an average reduction of 4.7 monthly migraine days, while patients receiving 240 mg experienced an average reduction of 4.6 days, compared to an average reduction of 2.8 days for placebo. In the similarly designed EVOLVE-2 study, patients receiving the 120 mg dose of galcanezumab experienced an average reduction of 4.3 monthly migraine days, compared to 4.2 days in the 240 mg group and 2.3 days for the placebo group. Additionally, patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities. Findings from the three-month REGAIN study were similar, with an average reduction of 4.8 days for 120 mg and 4.6 days for 240 mg as compared to 2.7 days for placebo.
In these three studies, the most common adverse events were injection site reactions, including pain, according to the company. The observed safety and tolerability profile was consistent with findings from previous studies of galcanezumab.
Lilly will present detailed data from these studies at scientific meetings later this year and also plans to submit a Biologics License Application to the FDA in the second half of 2017. The company is also evaluating galcanezumab for the treatment of cluster headache, with Phase 3 trial results expected in 2018.Next Story