Eli Lilly and Company (Basingstoke, UK) have announced that Emgality® (galcanezumab) has met the primary and all key secondary outcomes in a Phase III clinical trial evaluating the efficacy and safety of the drug (the CONQUER study).
CONQUER was a Phase III, double-blind, global study conducted in 12 countries, which enrolled 462 people with chronic migraine (n = 193) or episodic migraine (n = 269) who had a documented history of treatment failures on two to four different standard-of-care migraine preventive medication categories.
Treatment failures were identified as 1) inadequate efficacy after at least 2 months of treatment at the maximum tolerated dose, or 2) discontinuation of the medication for reasons over safety/tolerability.
At baseline within the study, participants had 13.2 average monthly migraine headache days. Following a screening and prospective baseline period, eligible participants were randomized 1:1 to receive Emgality 120 mg per month (with a loading dose of 240 mg) or placebo for 3 months. Individuals who completed this double-blind treatment were able to enter a 3-month open-label treatment phase with Emgality.
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In the 3-month, double-blind period of the study, researchers revealed that the primary objective was met; galcanezumab demonstrated superiority to placebo in the overall mean change from baseline in the number of monthly migraine headache days across 3 months. Treatment with galcanezumab was reported to reduce monthly migraine headache days by 4.1 days compared with 1 day in the placebo group.
In addition to this, the study achieved statistical significance on all key secondary outcomes including 50%, 75% and 100% response rates and improvements in the migraine-specific quality of life questionnaire role function-restrictive (MSQ-RFR) domain. Details of the key secondary outcomes will be presented at an upcoming scientific congress.
The safety profile of galcanezumab observed in the CONQUER study is stated to be consisted with the safety profile observed in Phase III studies of individuals with migraine and cluster headache that are treated with the drug.