AEON Biopharma Reports Initial Phase 2 Results for ABP-450 in Chronic Migraine Prevention

May 03, 2024 -- AEON Biopharma, Inc. (NYSE: AEON), a clinical-stage biopharmaceutical company, recently announced preliminary top-line results from the interim analysis of its Phase 2 trial involving ABP-450 for the preventive treatment of chronic migraine. Unfortunately, the trial did not meet its primary endpoint.

The primary endpoint focused on the mean reduction in monthly migraine days (MMD) over weeks 13 to 24 in a study involving 325 patients. These patients were divided into three groups: one receiving 150 U of ABP-450, another receiving 195 U, and the third receiving a placebo. The results showed a reduction of 8.5 days in the 150 U group and 7.7 days in the 195 U group, compared to an 8.4-day reduction in the placebo group. The differences between the groups did not achieve statistical significance (p=0.9132 for the 150 U arm and p=0.3611 for the 195 U arm). While the reductions in MMDs for the active arms were within the expected range, the placebo group showed a much higher reduction than anticipated based on prior studies. Furthermore, none of the secondary endpoints achieved statistical significance.

Given these results, AEON will continue to evaluate the complete dataset and determine the next steps for ABP-450's development. In light of these findings, the company has initiated immediate cash preservation measures and will review all strategic options.

Marc Forth, President and CEO of AEON, expressed his disappointment, noting that while the ABP-450 did not show statistically significant superiority over the placebo, both active arms demonstrated the expected reduction in monthly migraine days. He emphasized that additional analyses are underway to understand the unexpected placebo effect and to assess the results of the study comprehensively. Forth also extended gratitude to the patients, clinical investigators, and the AEON team for their dedication to the trial.

AEON Biopharma, Inc. is dedicated to the development of its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, particularly for debilitating medical conditions with a primary focus on the neurosciences market. Currently, ABP-450 is the same botulinum toxin complex approved and marketed for cosmetic uses under the name Jeuveau by Evolus. It is manufactured by Daewoong in compliance with current Good Manufacturing Practice (cGMP) standards in a facility approved by the U.S. FDA, Health Canada, and the European Medicines Agency (EMA).

AEON holds exclusive development and distribution rights for the therapeutic indications of ABP-450 across the United States, Canada, the European Union, the United Kingdom, and other international territories. The company boasts a highly experienced management team with expertise in biopharmaceutical and botulinum toxin development and commercialization.

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