AEON Biopharma, Inc. provided an update on the status of its late-stage clinical pipeline for ABP-450 that targets multiple indications. Portfolio Overview: Migraine. Episodic Migraine - Completed Phase 2 study of ABP-450 for the preventive treatment of episodic migraine.

The Company recently held a productive end-of-Phase 2 (EOP2) meeting with the U.S. FDA to present the Company's Phase 2 episodic migraine study results, which demonstrated a favorable safety profile for patients with episodic migraine and achieved key prespecified secondary endpoints, although it did not statistically separate from placebo with respect to the primary endpoint. The EOP2 meeting resulted in preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trial. Chronic Migraine - Ongoing analysis of interim data from the Phase 2 study of ABP - chronic migraine, which did not achieve its primary or secondary endpoints.

Cervical Dystonia - Ready to initiate a Phase 3 study of ABP-450 in cervical dystonia (CD), pending finalization of the trial protocol. The Phase 2 study of ABP the adults with CD met primary and secondary endpoints with statistical significance in reducing signs and symptoms associated with CD. The Company presented the Phase 2 CD clinical data at TOXINS 2024 Conference (click here).

Gastroparesis - Ready for a Phase 2 study ofABP-450 in gastroparesis; IND already cleared by the FDA. Post-Traumatic Stress Disorder (PTSD) - IND-enabling studies are already planned, which are designed to support the development of ABP-450 in PTSD. The Company recently presented pilot data at the TOXINS 2024 Conference that confirm the accurate delivery of combination doses of lidocaine and ABP-450, with evidence of appropriate Stellate Ganglion Block (SGB) targeting without significant signs of toxicity.

The Company believes these pilot data support future studies of ABP-450 as a potential treatment of PTSD.