– FDA and AEON align on the design and endpoints for the proposed pivotal Phase 3 trials for the preventive treatment of both episodic and chronic migraine –
– An interim analysis from the ongoing Phase 2 study in chronic migraine will now be conducted and data are expected in Q2 2024; previously stated timeline for top-line data on the complete cohort remains on track for Q3 2024 –
“We are pleased to announce a productive end-of-Phase 2 meeting with the FDA, during which we aligned on the proposed study design and the primary endpoint for the pivotal Phase 3 program with ABP-450 injection for the preventive treatment of episodic and chronic migraine,” commented
“We are excited to announce the advancement of our migraine program. The dedication and hard work of our clinical and regulatory teams have been essential in bringing us to this point, and we are incredibly thankful for their efforts,” commented
The ongoing Phase 2 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. In
The interim analysis will include approximately 100 chronic migraine patients in each of the three arms that have completed the two 12-week treatment cycles. At the end of Phase 2 (EOP2) meeting, the FDA confirmed the primary endpoint to evaluate the change in mean monthly migraine days (MMD) across the entire second injection cycle (weeks 13-24) relative to the 4-week baseline period, as compared to placebo. The EOP2 meeting also confirmed the use of this same primary endpoint for the final analysis of the Phase 2 chronic migraine cohort, as well as for the planned Phase 3 studies in the prevention of both episodic migraine and chronic migraine. This 12-week evaluation period (weeks 13-24) will also flow through to the secondary endpoints and was based on the improved effect observed in the Phase 2 episodic migraine study. The key secondary outcome measures for the chronic migraine group will include the percentage of patients achieving a reduction of ≥50% in MMD from the 4-week baseline period to Weeks 13 to 24 treatment period, the percentage of patients achieving a reduction of ≥75% in MMD from the 4-week baseline period to Weeks 13 to 24 treatment period, the change in mean monthly headache days (MHD) from the 4-week baseline period to Weeks 13 to 24 treatment period, and overall mean change from baseline in MHD throughout the study.
About Migraine
Migraine is a complex neurological disease characterized by recurrent episodes of headaches that affects approximately 40 million people in
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
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 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) 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
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:
+1 212 915 2577
cdavis@lifesciadvisors.com
Source: AEON Biopharma
Source: AEON Biopharma
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