Full Press Release Details
Announces Preliminary Top-Line Results from Phase 2 Interim Analysis of ABP-450 in the Preventive Treatment of Chronic Migraine
Trial did not meet primary endpoint -
IRVINE, Calif., May 3, 2024 - AEON Biopharma, Inc. ("AEON"
or the "Company") (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin
complex for the treatment of multiple debilitating medical conditions, today announced that the preliminary top-line results from its
planned interim analysis of the Phase 2 trial with ABP-450 in the preventive treatment for chronic migraine did not meet the primary endpoint.
The primary endpoint of mean reduction in monthly
migraine days (MMD) over the period 13-24 weeks in a total of 325 analyzed patients randomized across three arms showed a reduction of
8.5 days in the 150 U arm and 7.7 days in the 195 U arm, compared with a reduction of 8.4 days in the placebo arm. These differences did
not achieve statistical significance (p=0.9132 in 150 U arm; p=0.3611 in 195 U arm). The numerical reduction in MMDs were in the expected
range for the two active arms, however, the reduction in the placebo arm was much higher than expected based on previous studies. In addition,
none of the secondary endpoints met statistical significance. While the Company will continue to evaluate the complete dataset and determine
the next steps in the development of ABP-450, it has immediately commenced cash preservation measures and will review all strategic options.
"While we were surprised and disappointed
that ABP-450 did not demonstrate statistically significant superiority over placebo in this interim readout, both active arms showed a
reduction in monthly migraine days directly in-line with our expectations. We are conducting additional analyses of the interim data to
understand the highly abnormal and unexpected placebo effect and further evaluate the results of this study to determine the best path
forward in the development of ABP-450 for the preventive treatment of migraine," said Marc Forth, President and Chief Executive
Officer of AEON. "We want to express our gratitude to the patients who participated in this trial, the clinical investigators, and
the AEON team for their hard work and dedication to this study."
About AEON Biopharma
AEON is a clinical stage biopharmaceutical company focused on developing
its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with
an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for
cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing
Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, or the FDA, Health Canada and European
Medicines Agency, or EMA. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United
States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced
management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about
AEON, visit www.aeonbiopharma.com.
in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON's
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press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved
or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking
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Source: AEON Biopharma