AEON Biopharma, Inc., and Priveterra Acquisition Corp., a special purpose acquisition company (SPAC), announced the completion of patient enrollment in the Phase 2 study of ABP-450 for the preventive treatment of episodic migraine. The Company expects to announce topline data from the study in the second half of 2023. The Phase 2 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of ABP-450 for the prevention of episodic migraine in adults who suffer from fewer than 15 headache days per month and between 6 to 14 migraine days per month.

The study has enrolled a total of 302 patients across approximately 50 sites in the United States, Canada and Australia. Patients have at least a one-year history of episodic migraine (with or without aura) according to the ICHD-3 (2018) definition and diagnostic criteria. Study subjects were randomized evenly across a low dose group receiving 150 units of ABP-450, a high dose group receiving 195 units of ABP-450, and a placebo group.

All patients will receive two treatment cycles utilizing the Company's novel treatment paradigm involving fewer injections than the current botulinum toxin treatment option for chronic migraine. The primary outcome measure is the mean change in the number of migraine days at six months. Secondary outcome measures include the percentage of patients with at least a 50% reduction in monthly migraine days and the number of rescue medication days per month.

Migraine is a complex neurological disease characterized by recurrent episodes of headaches that affects approximately 40 million people in the United States and approximately a billion people worldwide, making migraine the third most prevalent illness in the world1. Migraine is ranked globally as the seventh most disabling disease among all diseases and the leading cause of disability among all neurological disorders2. Patients that live with migraine experience symptoms that include recurring throbbing headache pain, nausea, vomiting, and sensitivity to light, sound, touch and smell.

Migraine can be categorized as episodic migraine or chronic migraine. The Company projects that approximately 9.4 million Americans live with episodic migraine, which is characterized by fewer than 15 headache days per month and between 6 to 14 migraine days per month, but each individual attack can be just as debilitating.