IRVINE, Calif. - AEON Biopharma, Inc. (NYSE: AEON, AEON WS) has announced a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the upcoming Phase 3 trials for ABP-450 (prabotulinumtoxinA) injection, a treatment aimed at preventing both episodic and chronic migraine. Following positive Phase 2 data in episodic migraine released in October 2023, AEON is now set to conduct an interim analysis of its ongoing Phase 2 study in chronic migraine, with results expected in the second quarter of 2024.
The company, which specializes in developing proprietary botulinum toxin complexes for debilitating medical conditions, confirmed that the FDA had agreed on the design and primary endpoint for the Phase 3 trials. The primary endpoint will assess the change in mean monthly migraine days across a 12-week period, compared to a placebo.
The current Phase 2 study, which completed patient enrollment in December 2023, includes 492 participants across approximately 50 sites in the United States, Canada, and Australia. The interim analysis will focus on approximately 100 chronic migraine patients from each of the three study arms, who have completed two 12-week treatment cycles.
Marc Forth, President and CEO of AEON, expressed gratitude to the clinical and regulatory teams, as well as patients, caregivers, and investigators for their dedication to the study. He highlighted that the interim analysis is statistically powered to demonstrate the efficacy of ABP-450 in chronic migraine prevention.
Migraine, a neurological disease with symptoms including headache, nausea, and sensitivity to sensory stimuli, affects around 40 million people in the U.S. and approximately a billion worldwide. ABP-450, which has been developed by AEON, aims to provide relief by blocking peripheral acetylcholine release at nerve terminals, thus reducing muscle tension.
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