AEON Reports Expanded Structural Data Supporting Molecular Similarity Of ABP-450 To BOTOX
(RTTNews) - AEON Biopharma, Inc. (AEON) announced expanded structural analysis supporting the molecular similarity of ABP-450 to BOTOX, as the company advances ABP-450 as a biosimilar to BOTOX for therapeutic indications in the U.S.
The company said complementary peptide-mapping methods increased coverage of the active botulinum neurotoxin primary sequence from approximately 93% to 98%, with 100% amino acid identity across all regions analyzed.
The expanded analysis was conducted across six drug product samples encompassing ABP-450 and BOTOX.
AEON said the amino acid sequence was identical across every region analyzed, including the critical proteolytic activation junction between the light and heavy chains.
Preliminary disulfide bond characterization also identified the same C430-C454 bond connecting the light and heavy chains in both products across all tested lots. The disulfide-linked form represented approximately 99% of total species in each product.
AEON said primary amino acid sequence and disulfide connectivity are foundational attributes for establishing molecular similarity between ABP-450 and BOTOX.
The latest results expand on the approximately 93% sequence coverage reported in November 2025 and close most remaining coverage gaps within the active neurotoxin.
The company noted that the presence of the same disulfide bond at comparable abundance in both products is consistent with the highly similar potency previously reported for ABP-450 and BOTOX.
In March 2026, AEON reported feedback from its January 2026 Biosimilar Biological Product Development (BPD) Type 2a meeting with the U.S. Food and Drug Administration (FDA).
The agency reviewed AEON's proposed analytical similarity strategy under the 351(k) biosimilar pathway and provided feedback supporting the company's planned analytical development approach.
AEON expects feedback from a planned BPD Type 2b interaction with the FDA in the second half of 2026. The interaction is expected to help inform the next phase of ABP-450 development, including clinical pharmacology and comparative clinical study requirements.
ABP-450 is the same botulinum toxin complex approved and marketed by Evolus, Inc. under the name Jeuveau for cosmetic indications.
AEON is developing ABP-450 for therapeutic indications and holds exclusive development and distribution rights for therapeutic indications in the U.S., Canada, the European Union, the U.K., and certain other international territories.
AEON has traded between $0.22 and $1.45 over the past year. AEON closed Tuesday 's trading at $0.24, down 4.11%. In premarket trading today, the stock is down 0.23% at $6.91.
