AEON Biopharma Updates Development Pipeline

AEON Biopharma, Inc. (NYSE: AEON), a clinical-stage biopharmaceutical company, has recently shared updates on its clinical pipeline for ABP-450, a proprietary botulinum toxin complex aimed at treating several serious medical conditions. The company is advancing both late-stage and early-stage clinical programs.

Marc Forth, President and CEO of AEON, expressed optimism despite a setback in their interim Phase 2 results for chronic migraine, where ABP-450 did not achieve statistically significant superiority over placebo. Nevertheless, the company remains committed to its migraine program, supported by a newly issued patent (U.S. Patent No. 11,826,405) for their innovative migraine injection paradigm. Forth emphasized the strong scientific rationale for continuing trials for other indications.

AEON’s clinical portfolio includes the following key areas:

1. Migraine:
- Episodic Migraine: The Phase 2 study for the preventive treatment of episodic migraine has been completed. The study showed a favorable safety profile and met key secondary endpoints, although it did not show statistical separation from placebo on the primary endpoint. A productive end-of-Phase 2 (EOP2) meeting with the U.S. FDA has led to preliminary agreement on the design and endpoints for a pivotal Phase 3 trial.
- Chronic Migraine: Analysis is ongoing for interim data from the Phase 2 study, which did not meet its primary or secondary endpoints.

2. Cervical Dystonia (CD):
AEON is prepared to start a Phase 3 study for ABP-450 in cervical dystonia, pending the finalization of the trial protocol. The Phase 2 study showed significant results in reducing the signs and symptoms of cervical dystonia. These findings were presented at the TOXINS 2024 Conference.

3. Gastroparesis:
The company is ready to commence a Phase 2 study for ABP-450 in gastroparesis, with an Investigational New Drug (IND) application already cleared by the FDA.

4. Post-Traumatic Stress Disorder (PTSD):
IND-enabling studies are planned to support the development of ABP-450 for PTSD. Recently presented pilot data at the TOXINS 2024 Conference confirmed the precise delivery of combination doses of lidocaine and ABP-450, supporting future studies of ABP-450 as a potential PTSD treatment.

AEON Biopharma is focused on developing ABP-450 (prabotulinumtoxinA) injection for debilitating medical conditions, with an initial focus on the neuroscience market. ABP-450 is the same botulinum toxin complex marketed for cosmetic uses under the name Jeuveau by Evolus and is manufactured by Daewoong in compliance with good manufacturing practices. AEON holds exclusive rights for therapeutic applications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and other international markets.

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