Aeon’s results from Phase 2 trial of ABP-450 didn’t meet primary endpoint

AEON Biopharma announced that the preliminary top-line results from its planned interim analysis of the Phase 2 trial with ABP-450 in the preventive treatment for chronic migraine did not meet the primary endpoint. The primary endpoint of mean reduction in monthly migraine days, MMD, over the period 13-24 weeks in a total of 325 analyzed patients randomized across three arms showed a reduction of 8.5 days in the 150 U arm and 7.7 days in the 195 U arm, compared with a reduction of 8.4 days in the placebo arm. These differences did not achieve statistical significance. The numerical reduction in MMDs were in the expected range for the two active arms, however, the reduction in the placebo arm was much higher than expected based on previous studies. In addition, none of the secondary endpoints met statistical significance. While the Company will continue to evaluate the complete dataset and determine the next steps in the development of ABP-450, it has immediately commenced cash preservation measures and will review all strategic options.