Eli Lilly's Migraine Drug Hits Goal in Phase 3 Studies

Eli Lilly is getting closer to leading the migraine treatment space.

The company reported today that its investigational therapy galcanezumab for episodic and chronic migraine achieved the primary endpoint in three late-stage studies.

Galcanezumab is a monoclonal antibody designed to target a protein linked to pain signaling called calcitonin gene related peptide (CGRP).

Investigators running two studies titled EVOLVE-1 and EVOLVE-2 gave patients with episodic migraines 120 mg and 240 mg doses of galcanezumab over a six month period.

Results indicated the drug was able to produce a significantly greater decrease in the average number of monthly migraine headache days versus patients taking placebo.

The average reduction for patients in EVOLVE-1 receiving the 120 mg dose was 4.7 days while it was 4.6 days for the 240 mg group. Similar results were seen in EVOLVE-2 with the average reduction of patients taking 120 mg reaching 4.3 days whereas the 240 mg group saw the average reduction hit 4.2 days.

By contrast, the placebo results for EVOLVE-1 hit 2.8 days and 2.3 days in EVOLVE-2.

A third study focused on patients with chronic migraine receiving similar doses over a three-month treatment period.

Overall, the drug was able to produce a significantly greater decrease in the average number of monthly migraine headache days when compared to placebo. The average reduction of migraine days was 4.8 on 120 mg and 4.6 for 240 mg.

Galcanezumab met a number of pre-specified secondary endpoints like response rates and measures of daily activities.

“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 in a statement. 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.”

An estimated 38 million Americans suffer from migraines, according to the Migraine Research Foundation.

Another Phase 3 study evaluating the drug’s ability to treat cluster headaches will report results in 2018, but Eli Lilly will still submit a Biologics License Application to the Food and Drug Administration in the second half of this year.

There are other prominent companies in this treatment space racing to get the first official regulatory approval. Amgen and Novartis are collaborating on the migraine drug, erenumab. Two doses of their candidate lowered the average number of migraine days for patients with episodic migraines by 3.2 and 3.7 respectively.

They hope erenumab distinguishes itself from the competition because it blocks the CGRP receptor while others only target the ligand.