Lilly’s galcanezumab meets primary endpoint in three Phase III trials for migraine

14th May 2017 (Last Updated May 14th, 2017 18:30)

US-based healthcare firm Eli Lilly and Company has reported positive results from three Phase III EVOLVE-1, EVOLVE-2 and REGAIN clinical trials of galcanezumab to prevent episodic and chronic migraine.

US-based healthcare firm Eli Lilly and Company has reported positive results from three Phase III EVOLVE-1, EVOLVE-2 and REGAIN clinical trials of galcanezumab to prevent episodic and chronic migraine.

Galcanezumab is a monoclonal antibody developed to specifically inhibit the activity of calcitonin gene-related peptide (CGRP).

The results from the trials showed that both 120mg and 240mg doses of the drug met the primary endpoint of a statistically significant decrease in the number of migraine headache days per month.

Lilly Bio-Medicines president Christi Shaw said: "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.

"The impact of migraine is underestimated, with people who experience migraine attacks often missing work, family activities or social engagements.

"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."

“For patients with as few as one migraine headache day per week, this can mean more than 50 days of lost productivity a year."

All the three trials were randomised, double-blind, placebo-controlled and assessed the safety and efficacy of subcutaneous galcanezumab.

While EVOLVE-1 and EVOLVE-2 were conducted for a period of six-months, REGAIN included a treatment period of three months.

The trials’ secondary endpoints such as response rates and measures of daily activities were also found to be significantly improved.

The observed safety and tolerability profile was found to be consistent with data from previous trials of the drug.

Lilly intends to submit a biologics licence application to the US Food and Drug Administration (FDA) for galcanezumab in the second half of this year, based on these results.