Phase III ADVANCE trial of atogepant meets primary endpoint in migraine.- AbbVie

AbbVie announced that the Phase III ADVANCE trial evaluating the investigational medicine atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses across the 12-week treatment period. With these results, combined with the prior positive Phase II/III trial, AbbVie plans to move forward with regulatory submissions in the United States and other countries. Full data results will be presented at an upcoming medical congress and/or published in a peer-reviewed journal. The pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the prevention of migraine in those with 4 to 14 migraine days per month. The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All atogepant dose groups met the primary endpoint and demonstrated statistically significantly greater decreases in mean monthly migraine days compared to placebo. Patients treated in the 10 mg/30 mg/60 mg atogepant arms experienced a decrease of 3.69/3.86/4.2 days, respectively, all compared to patients in the placebo arm, who experienced a decrease of 2.48 days (all dose groups vs. placebo, p=<.0001). a key secondary endpoint measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. the trial demonstrated that 55.6% 58.7% 60.8% of patients in the 10 mg 30 mg 60 mg atogepant arms, respectively, achieved at least a 50% reduction, compared to 29.0% of patients in the placebo arm (all dose groups vs. placebo, p=""><.0001). no new safety risks were observed compared to the safety profile observed in the previous trial evaluating atogepant.>