Galcanezumab Meets Migraine Reduction Goals in Three Phase 3 Trials

The investigational treatment galcanezumab has met its primary endpoint of monthly migraine reduction in three separate phase 3 trials, according to a press release from the drug’s manufacturer. 

Galcanezumab (Eli Lilly and Company) is a monoclonal antibodies that binds to and inhibits the activity of calcitonin gene-related peptide. It is self-administered as a once-monthly injection. 

“The robust results from these three studies bring us one step closer to helping people experience more migraine-free days, an important treatment goal for those living with this serious disease,” Christi Shaw, president of Lilly Bio-Medicines, said in the press release.

In two of the trials, EVOLVE-1 and EVOLVE-2, patients who received 120 mg and 240 mg doses of galcanezumab over a 6-month treatment period showed a decrease in average monthly migraine headache days compared with those given placebo (P < .001). Chronic migraine patients who received similar doses of the monoclonal antibodies during the the 3-month REGAIN study also experienced a reduction in average migraine headache days (P < .001). Further, participants in all three studies demonstrated improvement in several prespecified secondary endpoints, including response rates and measures of daily activities.

Detailed data and findings from these studies will be presented at meetings and submitted to journals in the coming year, the manufacturer wrote. However, based on these results, Eli Lilly said that it already has plans to submit a Biologics License Application to the FDA in the latter half of 2017, and to other regulatory agencies at a later date.

“The topline results from these Phase 3 data are encouraging and reaffirm the potential for galcanezumab to provide a new option for people living with migraine,” Robert Conley, MD, global development leader for migraine therapeutics at Eli Lilly, said in the release. —Dave Muoio