AEON Biopharma Provides Update on Development Pipeline
AEON Biopharma, Inc. provided an update on its development pipeline, highlighting late-stage and early-stage clinical programs. The company focuses on a botulinum toxin complex for treating medical conditions. While ABP-450 did not show superiority over placebo in chronic migraine, the company remains optimistic about its migraine program and other indications. The portfolio includes studies on episodic migraine, cervical dystonia, gastroparesis, and PTSD.
Productive EOP2 meeting with the FDA for episodic migraine study results
Statistically significant results in reducing signs and symptoms of cervical dystonia in Phase 2 study
Pilot data supporting ABP-450 potential treatment for PTSD presented at TOXINS 2024 Conference
ABP-450 did not demonstrate superiority over placebo in chronic migraine Phase 2 study
Interim data analysis from chronic migraine study did not meet primary or secondary endpoints
Includes two late-stage clinical programs and two early-stage clinical programs
IRVINE, Calif., May 09, 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 provided an update on the status of its late-stage clinical pipeline for ABP-450 that targets multiple indications.
“In addition to our early-stage clinical programs, we have multiple late-stage programs designed to show the safety and efficacy of ABP-450 in the treatment of various indications. Several of these programs are ready to advance into the next stage of clinical development. When taking into consideration our clinical pipeline and combining it with our differentiated business model, we see a number of compelling opportunities to pursue,” said Marc Forth, President and Chief Executive Officer of AEON. “While we were disappointed that ABP-450 did not demonstrate statistically significant superiority over placebo in its interim Phase 2 readout for chronic migraine, this does not diminish our enthusiasm for our migraine program, which includes our issued patent (U.S. Patent No. 11,826,405) for our novel migraine injection paradigm, nor the other indications that have well-founded scientific rationale to pursue in clinical trials.”
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-450 in 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-450 in 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 of ABP-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 (click here) 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.
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.
Source: AEON Biopharma
FAQ
What is the primary focus of AEON Biopharma's development pipeline?
AEON Biopharma's development pipeline focuses on a proprietary botulinum toxin complex for treating multiple medical conditions.
What indications are included in AEON Biopharma's late-stage clinical programs?
AEON Biopharma's late-stage clinical programs target multiple indications, including chronic migraine, cervical dystonia, gastroparesis, and PTSD.
Did ABP-450 demonstrate statistical significance in all clinical studies?
No, ABP-450 did not show statistical significance over placebo in the chronic migraine Phase 2 study.
What was the outcome of the Phase 2 study for cervical dystonia?
The Phase 2 study for cervical dystonia showed statistically significant results in reducing signs and symptoms associated with the condition.
What data was presented at the TOXINS 2024 Conference regarding ABP-450?
Pilot data supporting the potential treatment of PTSD with ABP-450 was presented at the TOXINS 2024 Conference.
