AEON Biopharma, Inc. (AEON) announced on Friday that its initial key findings from the Phase 2 study of ABP-450, used for preventive treatment of migraines, were unsuccessful in reaching its primary objective.
The primary goal of the study was to decrease the average number of monthly migraine days (MMD). However, ABP-450 displayed no significant advantage over the placebo in the preliminary evaluation.
The study segregated participants into three groups, two of which received ABP-450 while the third was given a placebo. The groups treated with ABP-450 showed a reduction in MMD by 8.5 days and 7.7 days, respectively, while the placebo group experienced an 8.4-day reduction.
Furthermore, the study failed to achieve statistical significance in any of the secondary objectives.
"We are currently analyzing the interim data to comprehend the atypically high and unforeseen placebo effect," said Marc Forth, President and CEO of AEON. "We hope to further scrutinize the results of this study to determine the most effective approach to the development of ABP-450 for migraine prevention."