Galcanezumab Reports Positive Results in 3 Migraine Studies
The monoclonal antibody will seek FDA approval this year.
An investigational treatment for episodic migraine (EM) and chronic migraine (CM) prevention has returned positive results in three Phase 3 studies Saturday, June 10.
Galcanezumab, an investigational monoclonal antibody designed for binding to and inhibiting calcitonin gene-related peptide (CGRP), also reported safety and tolerability findings consistent with previous studies. The most common adverse event (AE) in all 3 studies was injection site reactions.
CGRP is believed by researchers to play a role in migraine and cluster headaches, while galcanezumab is a once-monthly, self-administered injection being considered for CM and EM prevention.
In the first 2 studies — presented Saturday at the American Headache Society (AHS) annual meeting in Boston — patients with EM were treated with 120 mg and 240 mg doses of galcanezumab over 6 months. Both groups in both studies (EVOLVE-1 and EVOLVE-2) experienced significant decreases in the migraine headaches per month, compared to placebo patients. Treated patients also reported significant improvements at each month.
Versus placebo patients, a significantly greater percentage of treated patients treated with both dosages achieved at least a 50%, 75%, and 100% reduction in the number of migraine headache days during the 6-month study. The 2 studies combined had 1,773 participating patients.
The third study (REGAIN) reported CM patients treated with 120 mg and 240 mg doses of galcanezumab to have a significant decrease in the average number of monthly migraine headache days versus placebo patients over 3 months. REGAIN featured 1,113 participating and eligible CM patients.
The results shared at the AHS meeting represent a “crucial step forward” for patients who have not yet found an effective preventive therapy for either migraine symptom, Christi Shaw, president of Lilly Bio-Medicines, said.
“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,” Shaw said.
Lilly Bio-Medicines intends to 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. They will also submit their trial findins for publication in peer-reviewed journals in the coming year.
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