AEON Biopharma, Inc. (AEON) Friday said its preliminary top-line results from the interim analysis of Phase 2 study of ABP-450 for the preventive treatment of migraine did not meet primary goal.
The primary endpoint of the study was mean reduction in monthly migraine days (MMD). ABP-450 did not show statistically significant superiority over placebo in the interim readout.
The patients were randomized to three groups, out of which 2 groups received ABP-450 and one group received placebo. The reductions in MMD in the ABP-450 arms were 8.5 days and 7.7 days. In the placebo arm, it was 8.4.
Additionally, none of the secondary endpoints were met statistical significance.
"We are conducting additional analyses of the interim data to understand the highly abnormal and unexpected placebo effect and further evaluate the results of this study to determine the best path forward in the development of ABP-450 for the preventive treatment of migraine," said Marc Forth, President and Chief Executive Officer of AEON.
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