Eli Lilly and Company has reported positive data from the Phase III CONQUER study of Emgality (galcanezumab-gnlm) in patients who failed previous migraine preventive treatments.
The double-blind, global study was conducted in 12 countries and enrolled a total of 462 patients.
It evaluated the efficacy and safety of monoclonal antibody Emgality in the preventive treatment of chronic and episodic migraine in patients.
Lilly designed and conducted the CONQUER study based on observations from subgroup analyses of previous Phase III studies of Emgality.
Lilly Bio-Medicines Neurology Development vice-president Gudarz Davar said: “Preventive treatment failure has been a common occurrence among patients with migraine.
“The CONQUER study applied strict and rigorous criteria to identify and enrol patients with chronic and episodic migraine who had failed multiple migraine preventive treatments, with the goal of understanding whether Emgality may be an effective option for patients with such significant unmet need.”
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The CONQUER study enrolled patients with chronic or episodic migraine who experienced treatment failures to two to four different standard-of-care migraine preventive medication categories.
After completion of a screening and prospective baseline period, eligible patients were randomised 1:1 to Emgality 120mg per month or placebo for three months of double-blind treatment.
Patients who completed the double-blind treatment phase are expected to enter an open-label period with Emgality for three months.
The trial met its primary objective of demonstrating the superiority of Emgality versus placebo in the overall mean change from baseline in the number of monthly migraine headache days from months one to three.
Treatment with Emgality during the study reduced monthly migraine headache days by 4.1 (p<0.0001) compared to one day with placebo.
Additionally, the study achieved statistical significance on all key secondary outcomes.
Emgality secured approval from the US FDA in September of last year for the preventive treatment of migraine in adults.
In June, it also received FDA approval to treat episodic cluster headache in adults.