AEON Biopharma Completes Enrollment in Phase 2 Study of ABP-450 (prabotulinumtoxinA) for Preventive Treatment of Chronic Migraine

Rhea-AI Summary

AEON Biopharma, Inc. (NYSE: AEON, AEON WS) completes enrollment in Phase 2 study of ABP-450 for chronic migraine, with topline data expected in Q3 2024. The study will evaluate the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month.

– Expect to announce topline data in Q3 2024 –

– Company plans in Q1 2024 an end-of-phase 2 meeting with the FDA to discuss the Phase 3 program in episodic migraine –

– Anticipate shortening the open label extension (OLE) study to 2 treatment cycles –

IRVINE, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced today completion of enrollment with the last patient first visit in the Phase 2 study of ABP-450 for the preventive treatment of chronic migraine. The Company expects to announce topline data in the third quarter of 2024.

“We are excited to continue to successfully execute our clinical strategy with the completion of enrollment in the Phase 2 study of ABP-450 for chronic migraine. With the last patient enrolled in the study, we are narrowing our guidance for topline data from the study to the third quarter of 2024, which we had previously targeted for the second half of 2024. Compared to the episodic cohort, which enrolled approximately 70% of patients that appeared to be treatment naïve, the screening requirements in the chronic cohort will likely result in more treatment-experienced patients, which we believe should lower the placebo effect,” commented Marc Forth, AEON’s President and Chief Executive Officer. “We look forward to announcing the data from the chronic migraine cohort and advancing our chronic and episodic migraine programs into pivotal trials.”

The Phase 2 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month. The study has enrolled a total of 492 patients across approximately 50 sites in the United States, Canada and Australia. Patients have at least a one-year history of migraine (with or without aura) according to the ICHD-3 (2018) definition and diagnostic criteria. Study subjects were randomized evenly across a low dose group receiving 150 units of ABP-450, a high dose group receiving 195 units of ABP-450, and a placebo group. All patients will receive two treatment cycles utilizing the Company’s patented treatment paradigm (U.S. Patent No. 11,826,405) involving fewer injections than the current botulinum toxin treatment option for migraine.

For the primary efficacy endpoint, the Company now plans to evaluate the change in mean monthly migraine days, or MMD, across the entire second injection cycle (weeks 13-24) relative to the four-week baseline period, as compared to placebo. This change to the evaluation period, which will also flow through to the secondary endpoints, is based on prior discussions with the U.S. Food and Drug Administration (“FDA”) and the observed effect from the Phase 2 episodic migraine cohort. The study’s other endpoints remain essentially unchanged, which include the primary safety endpoint showing the incidence of treatment-emergent adverse events (“TEAEs”), as compared to placebo, and secondary outcome measures that include the evaluation of patients with at least a 50% reduction in monthly migraine days and the number of rescue medication days per month. The only other planned change to the study endpoints is to remove as a secondary endpoint the evaluation of patients with a 100% reduction in MMD, as the measure is not expected to be a meaningful indicator of efficacy.

The Company has also been in discussions with the FDA regarding adjusting the open label extension (OLE) study period from 48 weeks to 24 weeks to cover 2 treatment cycles instead of the current 4 treatment cycles. The Company is exploring this change with the hope that some of the patients who would have otherwise been enrolled in the OLE study will be available to participate in the Company’s planned Phase 3 migraine study. To date, there have been 421 patients enrolled in the OLE study across the episodic and chronic migraine Phase 2 cohorts. Participating patients who have already received 2 or 3 treatment cycles in the study will be informed of this update and will not receive additional cycles.

Chronic Migraine Program Next Steps - The Company expects to announce topline data from the study in the third quarter of 2024.

Episodic Migraine Program Next Steps – The Company plans to discuss the protocol and study design for a Phase 3 study at an end-of-phase 2 meeting with the FDA expected to take place in Q1 2024. The Company is evaluating multiple parameters for the Phase 3 trial that are expected to increase the statistical power and may reduce the observed higher placebo responses reported in the topline results of the Phase 2 study in episodic migraine.

About Migraine

Migraine is a complex neurological disease characterized by recurrent episodes of headaches that affects approximately 40 million people in the United States and approximately a billion people worldwide, making migraine the third most prevalent illness in the world. Patients who live with migraine experience symptoms that include recurring throbbing headache pain, nausea, vomiting, and sensitivity to light, sound, touch and smell. Migraine can be categorized as episodic migraine or chronic migraine. AEON projects that approximately 4 million Americans live with chronic migraine, which is characterized by 15 or more headache days per month and at least 8 migraine days per month.

About ABP-450 (prabotulinumtoxinA) Injection

ABP-450 contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum. The active part of the botulinum toxin is the 150 kDa component, and the remaining 750 kDa of the complex is made up of accessory proteins that the Company believes help with the function of the active portion of the botulinum toxin. When injected at therapeutic levels, ABP-450 blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings leading to denervation and relaxation of the muscle.

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. AEON recently completed a Phase 2 study of ABP-450 for the treatment of cervical dystonia, released topline data from its Phase 2 study of ABP-450 for the preventive treatment of episodic migraine, and has an ongoing Phase 2 study of ABP-450 for the preventive treatment of chronic migraine. 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 and the development of its uniquely positioned therapeutic neurotoxin, 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 continued listing on NYSE American, the anticipated timing of clinical results, the impact of current financing arrangements, the competitive environment in which AEON operates, AEON’s expected capital resources and liquidity needs and the expected future operating and financial performance and market opportunities of AEON are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "pro forma", "may", "should", "could", "might", "plan", "possible", "project", "strive", "budget", "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 agreements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) costs related to being a public company; (vi) changes in applicable laws or regulations; (vii) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (viii) AEON’s estimates of expenses and profitability; (ix) the evolution of the markets in which AEON competes; (x) the ability of AEON to implement its strategic initiatives, including the continued development of ABP-450; (xi) the ability of AEON to defend its intellectual property; (xii) the ability of AEON to satisfy regulatory requirements; (xiii) the impact of adverse geopolitical and macroeconomic developments, such as the COVID-19 pandemic, the Israel-Hamas conflict, the Ukraine-Russia conflict and related sanctions, actual and anticipated changes in interest rates, economic inflation and the responses by central banking authorities to control such inflation on AEON’s business; and (xiv) 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

When is AEON Biopharma, Inc. expected to announce topline data from the Phase 2 study of ABP-450 for chronic migraine?

AEON Biopharma, Inc. is expected to announce topline data in the third quarter of 2024.

What is the purpose of the Phase 2 study of ABP-450 for chronic migraine?

The Phase 2 study aims to evaluate the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month.

How many patients were enrolled in the Phase 2 study of ABP-450 for chronic migraine?

A total of 492 patients were enrolled across approximately 50 sites in the United States, Canada, and Australia.

What are the next steps for AEON Biopharma, Inc.'s chronic migraine program?

The company expects to announce topline data from the study in the third quarter of 2024.

What are the next steps for AEON Biopharma, Inc.'s episodic migraine program?

The company plans to discuss the protocol and study design for a Phase 3 study at an end-of-phase 2 meeting with the FDA expected to take place in Q1 2024.