AbbVie has reported positive data from the Phase III ADVANCE clinical trial of atogepant for the prevention of migraine in people who experience the condition four to 14 days per month.
Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant).
The multi-centre, randomised, double-blind, placebo-controlled, parallel-group ADVANCE trial compared the efficacy, safety and tolerability of a 10mg, 30mg and 60mg dose of the drug to placebo in a total of 910 patients.
Efficacy analyses involved the modified intent-to-treat (mITT) population of 873 patients.
The trial met its primary endpoint of a statistically significantly greater decrease in mean monthly migraine days versus placebo across all doses over the 12-week treatment period.
Patients on the 10mg, 30mg and 60mg dose had a reduction of 3.69, 3.86 and 4.2 days, respectively, compared to 2.48 days with placebo.
A key secondary endpoint was the proportion of participants with at least a 50% decrease in mean monthly migraine days over the treatment period.
Results found that 55.6%, 58.7% and 60.8% of participants in the 10mg, 30mg and 60mg groups, respectively, experienced at least a 50% decrease, compared to 29% of those treated with placebo.
The company added that the 30mg and 60mg doses led to statistically significant improvements on all secondary endpoints, while the 10mg dose showed statistically significance on four out of the six secondary endpoints.
Data showed no new safety risks compared to the profile observed in the previous trial of atogepant.
AbbVie R&D senior vice-president and chief scientific officer said: “Migraine attacks can be debilitating, but migraine is a treatable disease, and people living with it are not alone in their battle to control it.
“With the results from these trials, we aim to provide a safe and effective preventive treatment that offers patients and healthcare providers a simple, once daily oral treatment that works specifically by blocking CGRP receptors and preventing migraine.”
Earlier this month, AbbVie reported positive results from the Phase III Measure Up 2 trial of Rinvoq (upadacitinib) as a monotherapy in patients with moderate to severe atopic dermatitis.