AEON Biopharma's ABP-450 Migraine Treatment: FDA Phase 2 Progress and Meeting Outcome

AEON Biopharma, a biopharmaceutical company, has announced a successful end-of-Phase 2 meeting with the FDA regarding ABP-450, a botulinum toxin complex for treating migraines. The meeting followed positive data from a Phase 2 study on episodic migraine, and it has paved the way for ABP-450 to move into a pivotal Phase 3 program. AEON will now perform an interim analysis of the ongoing Phase 2 study for chronic migraine treatment and expects to release the data in the second quarter of 2024.

The company's President and CEO, Marc Forth, expressed satisfaction with the alignment on study design and primary endpoint for the Phase 3 program, which targets both episodic and chronic migraine prevention. The interim analysis will involve over 300 participants who have completed two 12-week treatment cycles, providing statistical power to demonstrate efficacy.

AEON's Phase 2 study for chronic migraine aims to assess the effectiveness and safety of ABP-450 in adults experiencing 15 or more headache days and at least 8 migraine days per month. The study, completed in December 2023, enrolled 492 patients across the United States, Canada, and Australia. Participants were randomized into groups receiving low and high doses of ABP-450 or a placebo, with treatment cycles 12 weeks apart.

The FDA confirmed the primary endpoint for the study, which is to evaluate the change in mean monthly migraine days over the second injection cycle compared to a baseline period. The same endpoint will be used for the final Phase 2 chronic migraine cohort analysis and the planned Phase 3 studies for migraine prevention.

Migraine is a prevalent neurological condition affecting around 40 million people in the U.S. and nearly a billion worldwide. It is characterized by recurring severe headaches, nausea, vomiting, and sensitivity to various stimuli. The condition can be divided into episodic and chronic forms, with the latter being particularly debilitating.

ABP-450 is a 900 kDa botulinum toxin type-A complex that works by blocking peripheral acetylcholine release, leading to muscle relaxation. It is manufactured under strict quality standards and has exclusive development and distribution rights in several international territories.

AEON Biopharma is a clinical-stage company with a focus on developing ABP-450 for various medical conditions, starting with the neurosciences market. The company has completed studies for cervical dystonia and episodic migraine and is conducting a study for chronic migraine. With a seasoned management team, AEON is committed to advancing therapeutic neurotoxins.

Migraine, a complex neurological disorder, is marked by recurring severe headache episodes, impacting approximately 40 million individuals in the United States and nearly a billion globally. The condition presents with symptoms such as throbbing headache pain, nausea, and heightened sensitivity to various stimuli. It is categorized into episodic and chronic forms, with the former affecting around 9.4 million Americans, characterized by fewer than 15 headache days and between 6 to 14 migraine days per month.

ABP-450, a botulinum toxin type-A complex developed by AEON Biopharma, is designed to treat debilitating medical conditions, with a primary focus on neurosciences. The compound contains an active 150 kDa component and accessory proteins that enhance its functionality. When administered therapeutically, ABP-450 inhibits peripheral acetylcholine release by cleaving SNAP-25, resulting in muscle denervation and relaxation.

AEON Biopharma is a clinical-stage biopharmaceutical company dedicated to the development of ABP-450 for a range of medical conditions, initially targeting the neurosciences market. The company has completed studies for cervical dystonia and episodic migraine and is currently conducting a study for chronic migraine. ABP-450 is manufactured under stringent quality standards and is approved for cosmetic use by Evolus under the name Jeuveau. AEON holds exclusive rights for therapeutic indications of ABP-450 in several international territories and is led by a highly experienced management team with expertise in biopharmaceutical and botulinum toxin development and commercialization.