AEON Biopharma, Inc. announced a productive end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) following the Phase 2 data in episodic migraine previously released in October 2023, that supports advancing ABP-450 (prabotulinumtoxinA) injection into the proposed pivotal Phase 3 program. As part of the updated development plan, the Company will now conduct an interim analysis of the ongoing Phase 2 study of ABP-450 for the preventive treatment of chronic migraine and anticipates releasing the data in the second quarter of 2024. The ongoing Phase 2 study will evaluate the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month.

In December 2023, the study completed the enrollment of 492 patients across approximately 50 sites in the United States, Canada, and Australia. Patients have at least a one-year history of 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 12 weeks apart utilizing the Company?s patented treatment paradigm (U.S. Patent No. 11,826,405) involving fewer injections than the current botulinum toxin treatment option for migraine. The interim analysis will include approximately 100 chronic migraine patients in each of the three arms that have completed the two 12-week treatment cycles.

At the end of Phase 2 (EOP2) meeting, the FDA confirmed the primary endpoint to evaluate the change in mean monthly migraine days (MMD) across the entire second injection cycle (weeks 13-24) relative to the 4-week baseline period, as compared to placebo. The EOP2 meeting also confirmed the use of this same primary endpoint for the final analysis of the Phase 2 chronic migraine cohort, as well as for the planned Phase 3 studies in the prevention of both episodic migraine and chronic migraine. This 12-week evaluation period (weeks 13-24) will also flow through to the secondary endpoints and was based on the improved effect observed in the Phase 2 episodic migraine study.

The key secondary outcome measures for the chronic migraine group will include the percentage of patients achieving a reduction of =50% in MMD from the 4-week baseline period to Weeks 13 to 24 treatment period, the percentage of patients achieving a reduction of =75% in MMD from the 4-week baseline period to Weeks 13 to 24 treatment period, the change in mean monthly headache days (MHD) from the 4-week baseline period to Weeks 13 to 24 treatment period, and overall mean change from baseline in MHD throughout the study.