AEON Biopharma Announces Preliminary Top-Line Results from Phase 2 Interim Analysis of ABP-450 in the Preventive Treatment of Chronic Migraine

Rhea-AI Summary

AEON Biopharma announced that the preliminary results from the Phase 2 trial with ABP-450 for chronic migraine prevention did not meet the primary endpoint of mean reduction in monthly migraine days. The trial showed no statistical significance in reduction compared to placebo, leading to the company initiating cash preservation measures and reviewing strategic options.

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• The Phase 2 trial with ABP-450 for chronic migraine prevention did not meet the primary endpoint of mean reduction in monthly migraine days. The trial did not show statistical significance in reduction compared to placebo, raising concerns about the drug's efficacy and future development.

Insights

Medical Research Analyst

AEON Biopharma's announcement concerning its Phase 2 trial of ABP-450 is of keen interest to stakeholders due to its implications on the company's research trajectory and financial outlook. The failure to meet the primary endpoint—mean reduction in monthly migraine days—suggests that there may be no significant difference in treatment effect between the drug and placebo. For investors, this indicates potential delays or alterations in the drug's development pipeline, which could impact projected revenues and R&D costs. Moreover, AEON's decision to implement cash preservation measures and explore strategic options highlights the need for a conservative approach to risk assessment when investing in clinical-stage biopharmaceutical companies. Given the inherent uncertainties of drug development, especially in the face of unexpected trial outcomes, the importance of a diversified investment portfolio becomes apparent.

Financial Analyst

The preliminary top-line results from AEON's Phase 2 trial are significant from a financial perspective. The lack of statistical significance in primary and secondary endpoints not only casts doubt on the efficacy of ABP-450 but also raises concerns about future funding needs and partnership opportunities for AEON. The company's stock price may face downward pressure as investors recalibrate expectations for the drug's market potential. Moreover, with AEON undertaking cash conservation measures, there is an implicit suggestion of a need to extend the runway until more favorable data can be presented or alternative strategies can be deployed. This could involve cost-cutting, downsizing, or seeking mergers and partnerships to keep operations afloat. Investors should monitor AEON's subsequent communications closely for updates on the full dataset analysis and any strategic partnerships that could mitigate the trial's impacts.

Biotech Industry Analyst

In the biotech industry, the clinical trial process is a critical determinant of a drug's fate. AEON Biopharma's Phase 2 clinical trial results for ABP-450 present a cautionary tale about the unpredictability of drug development. Notably, the placebo effect observed was stronger than anticipated, a phenomenon that can sometimes occur in pain-related conditions such as migraines. This could suggest placebo response variability in this indication, which is a vital insight for other companies in the migraine treatment space. However, the company's commitment to understanding the anomalous placebo effect indicates a pursuit of scientific rigor, which is commendable. Still, stakeholders should be aware of the amplified risks associated with investing in single-asset biotech firms where much rides on the success of one key product.

– Trial did not meet primary endpoint –

IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- 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.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding AEON’s expected capital resources and liquidity needs and the anticipated timing of AEON’s clinical results are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements, including with respect to potential obligations pursuant to the forward purchase agreement termination letters; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov.

Nothing in this 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 statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.

Contacts

Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Source: AEON Biopharma

FAQ

What were the primary endpoint results of the Phase 2 trial with ABP-450 for chronic migraine prevention?

The trial did not meet the primary endpoint of mean reduction in monthly migraine days, with no statistical significance in reduction compared to placebo.

What were the secondary endpoints results of the Phase 2 trial with ABP-450 for chronic migraine prevention?

None of the secondary endpoints met statistical significance in the trial.

What measures did AEON Biopharma announce following the Phase 2 trial results?

AEON Biopharma initiated cash preservation measures and will review all strategic options following the trial results.

Who is the President and CEO of AEON Biopharma?

Marc Forth is the President and Chief Executive Officer of AEON Biopharma.