New Migraine Drug Meets Endpoints of Phase III Trials

Eli Lilly’s galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine headaches, has met its primary endpoint in three phase III studies, according to a company statement.

The drug demonstrated statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses, the statement read.

“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,” said Christi Shaw, president of Lilly Bio-Medicines.

Based on these results, Eli Lilly will submit a Biologics License Application to the US Food and Drug Administration (FDA) for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.

The most commonly reported adverse events during the three studies were injection site reactions, including pain. The observed safety and tolerability profile was consistent with findings from previous studies of galcanezumab.

“The impact of migraine is underestimated, with people who experience migraine attacks often missing work, family activities or social engagements. For patients with as few as one migraine headache day per week, this can mean more than 50 days of lost productivity a year,” Shaw said.

The first two phase III trials — EVOLVE-1 and EVOLVE-2 – were conducted over six-month treatment periods. Patients with episodic migraines were treated with galcanezumab 120 mg and 240 mg doses, and experienced a significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo, the statement read.

In EVOLVE-1, patients experienced an average reduction of 4.7 days for 120 mg and 4.6 days of 240 mg compared to an average reduction of 2.8 days for placebo, p<0.001 for both dosing groups.

In EVOLVE-2, patients experienced an average reduction of 4.3 Days for 120 mg and 4.2 days for 240 mg compared to an average reduction of 2.3 days for placebo, p<0.001 for both dosing groups.

Moreover, 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.

The third phase III trial, called the REGAIN study, monitored patients over a three-month treatment period. During this time, patients with chronic migraines were treated with galcanezumab 120 mg and 240 mg doses. They experienced a significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo.

Patients experienced an average reduction of 4.8 days for 120 mg and 4.6 days for 240 mg, compared to an average reduction of 2.7 days for placebo, p<0.001 for both dosing groups.

Eli Lilly will present detailed data from the three phase III studies at scientific meetings later this year, and submit the results to peer-reviewed journals.