Eli Lilly and Company announced the positive results from three phase 3 studies of galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine, including late-breaking data on several key secondary endpoints for galcanezumab compared to placebo at both studied doses. Detailed results from these studies (EVOLVE-1, EVOLVE-2 and REGAIN) presented at the American Headache Society (AHS) annual scientific meeting in Boston.

"The detailed phase 3 results presented represent a crucial step forward for the millions of patients living with migraine who have not yet tried, or found, an effective preventive therapy," said Christi Shaw, president of Lilly Bio-Medicines. "Following more than 25 years of research in migraine, Lilly is excited to help usher in a new era of preventive migraine therapies that may substantially improve the current standard of care for people living with migraine."

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

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

In both studies, over the six-month treatment period, patients with episodic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo, with statistically significant improvements observed at each month starting at one month of treatment.

A statistically significantly greater percentage of patients treated with both doses of galcanezumab achieved at least a 50 percent, 75 percent and 100 percent reduction in the number of migraine headache days compared to placebo over the six-month treatment period, in both studies after multiplicity adjustment.

At least a 50 percent reduction: 62.3% for 120 mg and 60.9% for 240 mg compared to 38.6% for placebo, p < 0.001 for both dosing groups

At least a 75 percent reduction: 38.8% for 120 mg and 38.5% for 240 mg compared to 19.3% for placebo, p < 0.001 for both dosing groups

 100 percent reduction: 15.6% for 120 mg and 14.6% for 240 mg compared to 6.2% for placebo, p < 0.001 for both dosing groups

At least a 50 percent reduction: 59.3% for 120 mg and 56.5% for 240 mg compared to 36.0% for placebo, p < 0.001 for both dosing groups

At least a 75 percent reduction: 33.5% for 120 mg and 34.3% for 240 mg compared to 17.8% for placebo, p < 0.001 for both dosing groups

100 percent reduction: 11.5% for 120 mg and 13.8% for 240 mg compared to 5.7% for placebo, p < 0.001 for both dosing groups

Patients treated with galcanezumab in both studies also had a statistically significantly greater reduction of monthly migraine headache days with acute medication use compared to placebo over the six-month treatment period after multiplicity adjustment.

 EVOLVE-1: An average reduction of 4.0 days for 120 mg and 3.8 days for 240 mg compared to 2.15 days for placebo, p < 0.001 for both dosing groups

EVOLVE-2: An average reduction of 3.7 days for 120 mg and 3.6 days for 240 mg compared to 1.85 days for placebo, p < 0.001 for both dosing groups

Patients treated with both doses of galcanezumab also saw statistically significant improvement in physical function compared to placebo over the six-month treatment period, as measured by both the Role Function-Restrictive (RF-R) domain score of the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Patient Global Impression of Severity (PGI-S) rating after multiplicity adjustment.

Over the three-month treatment period, patients with chronic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo. Statistically significant improvements for both doses of galcanezumab were observed at each month starting at one month of treatment.

A statistically significantly greater percentage of patients also achieved at least a 50 percent reduction in the number of migraine headache days compared to placebo over the three-month treatment period (27.6% for 120 mg and 27.5% for 240 mg compared to 15.4% for placebo, p < 0.001 for both dosing groups) after multiplicity adjustment.

Compared with placebo over the three-month treatment period, a statistically significantly higher percentage of patients treated with the 240 mg dose of galcanezumab achieved at least a 75 percent reduction in the number of migraine headache days (8.8% compared to 4.5% for placebo, p < 0.001) after multiplicity adjustment. Patients treated with the 240 mg dose of galcanezumab also achieved a statistically significantly greater reduction in the number of monthly migraine headache days with acute medication use compared to placebo over the three-month treatment period (an average of 4.3 days compared to 2.2 days for placebo, p < 0.001) after multiplicity adjustment.

Patients treated with 240 mg of galcanezumab also saw statistically significant improvement in physical function compared to placebo over the three-month treatment period, as measured by both the RF-R domain score of the MSQ and PGI-S rating after multiplicity adjustment.