IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, today 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.

加利福尼亚州欧文市，2024年5月3日（环球通讯社）--AEON Biopharma，Inc.（“AEON”或“公司”）（纽约证券交易所：AEON），一家临床阶段的生物制药公司，专注于开发一种专有的肉毒杆菌毒素复合物，用于治疗多种衰弱性疾病，今天宣布，其计划对ABP-450预防性治疗慢性偏头痛的2期临床试验进行中期分析的初步结果未达到主要终点。

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 (p=0.9132 in 150 U arm; p=0.3611 in 195 U arm).

在总共325名随机分为三组的分析患者中，13-24周内每月偏头痛天数（MMD）平均减少的主要终点显示，150 U组减少了8.5天，195 U组减少了7.7天，而安慰剂组减少了8.4天。这些差异没有达到统计学意义（150 U臂p=0.9132；195 U臂p=0.3611）。

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.

MMD的数字减少在两个活动组的预期范围内，然而，安慰剂组的减少远高于先前研究的预期。此外，次要终点均未达到统计学显着性。虽然该公司将继续评估完整的数据集，并确定ABP-450开发的下一步，但它已立即开始采取现金保全措施，并将审查所有战略选择。

“While we were surprised and disappointed that ABP-450 did not demonstrate statistically significant superiority over placebo in this interim readout, both active arms showed a reduction in monthly migraine days directly in-line with our expectations. 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 determi.

“虽然我们对ABP-450在这个中期读数中没有显示出比安慰剂有统计学意义上的显着优势感到惊讶和失望，但两个活跃的手臂显示每月偏头痛天数的减少直接符合我们的预期。我们正在对中期数据进行额外分析，以了解高度异常和意外的安慰剂效应，并进一步评估这项研究的结果以确定偏头痛。