AEON Biopharma, Inc. announced completion of enrollment with the last patient first visit in the Phase 2 study of ABP-450 for the preventive treatment of chronic migraine. The Company expects to announce topline data in the third quarter of 2024. For the primary efficacy endpoint, the Company now plans to evaluate the change in mean monthly migraine days, or MMD, across the entire second injection cycle (we weeks 13-24) relative to the four-week baseline period, as compared to placebo.

This change to the evaluation period, which will also flow through to the secondary endpoints, is based on prior discussions with the U.S. Food and Drug Administration ("FDA") and the observed effect from the Phase 2 episodic migraine cohort. The study's other endpoints remain essentially unchanged, which include the primary safety endpoint showing the incidence of treatment-emergent adverse events ("TEAEs"), as compared to placebo, and secondary outcome measures that include the evaluation of patients with at least a 50% reduction in monthly migraine days and the number of rescue medication days per month. The only other planned change to the study endpoints is to remove as a secondary endpoint the evaluation of patients with a 100% reduction in MMD, as the measure is not expected to be a meaningful indicator of efficacy.

The Company has also been in discussions with the FDA regarding adjusting the open label extension (OLE) study period from 48 weeks to 24 weeks to cover 2 treatment cycles instead of the current 4 treatment cycles. The Company is exploring this change with the hope that some of the patients who would have otherwise been enrolled in the OLE study will be available to participate in the Company's planned Phase 3 migraine study. To date, there have been 421 patients enrolled in the OLE study across the episodic and chronic migraine Phase 2 cohorts.

Participating patients who have already received 2 or 3 treatment cycles in the study will be informed of this update and will not receive additional cycles. Chronic Migraine Program Next Steps - The Company plans to discuss the protocol and study design for a Phase 3 study at an end-of-phase 2 meeting with the FDA expected to take place in first quarter of 2024. The Company is evaluating multiple parameters for the Phase 3 trial that are expected to increase the statistical power and may reduce the observed higher placebo responses reported in the topline results of the Phase 2 study in episodic migraine.