Lilly Announces Positive Phase 3 Results for Emgality (galcanezumab) in Migraine Patients Who Failed Prior Preventive Therapies

Today, Eli Lilly and Company announced that its new drug Emgality (galcanezumab-gnlm) achieved positive results in the Phase 3 clinical trial CONQUER: significantly reducing the number of migraine days in patients with chronic and episodic migraine who had previously failed standard-of-care preventive treatments.

Migraine is a disabling neurological disorder characterized by recurrent episodes of severe headache, accompanied by other symptoms such as nausea, vomiting, sensitivity to light and sound, and visual disturbances. As a highly prevalent neurological condition, migraine affects the lives of one billion people worldwide and ranks as the sixth leading cause of disability globally. While some patients experience only one or two headache attacks per month, more than 4 million patients suffer from chronic migraine, defined as having headache days on at least 15 days per month. It is estimated that over 40% of patients worldwide either fail to respond to migraine preventive medications or require a change in therapy. There is an urgent need for innovative therapies to prevent migraine attacks.

Emgality is a humanized monoclonal antibody targeting calcitonin gene-related peptide (CGRP) that plays a significant role in the pathogenesis of headache attacks. By binding to CGRP, it blocks the interaction between CGRP and its receptor, thereby offering the potential to alleviate and improve headache symptoms. Last September, this innovative therapy was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults.

CONQUER is a Phase 3, double-blind clinical trial conducted in 12 countries. The study enrolled 462 patients with chronic (n=193, 41.7%) or episodic migraine (n=269, 58.2%), who had documented failures of two to four different classes of standard preventive migraine medications. At baseline, patients experienced an average of 13.2 migraine days per month. Following the screening and prospective baseline periods, eligible patients were randomized in a 1:1 ratio to receive either Emgality or placebo for a 3-month double-blind treatment period. Patients who completed the double-blind treatment phase could enter a 3-month open-label Emgality treatment phase.

Studies have shown that patients treated with Emgality experienced a reduction of 4.1 days in monthly migraine days, whereas those treated with placebo had a reduction of 1.0 day in monthly migraine days.

References:

[1] Lilly Announces Positive Results for Emgality^® (galcanezumab-gnlm) from the CONQUER Study in Patients who Failed Previous Migraine Preventive Treatments. Retrieved August 5, 2019, from https://investor.lilly.com/news-releases/news-release-details/lilly-announces-positive-results-emgalityr-galcanezumab-gnlm

Headline: Flash | Positive Phase 3 Results for Eli Lilly’s CGRP Inhibitor in Migraine Patients Who Failed Preventive Therapy

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