The poster titled, “A Phase 2, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of ABP-450 (PrabotulinumtoxinA) in Adults With Isolated Cervical Dystonia,” was presented by
“These Phase 2 data presented at IP-MDS are important to this program because the TWSTRS scores and safety data further support our strategy to pursue ABP-450 as an approved therapy for CD,” commented
About AEON’s Phase 2 Cervical Dystonia Trial
The Phase 2 trial (ClinicalTrials.gov Identifier: NCT04849988) is a randomized, double-blind, placebo-controlled study that analyzed a total of 57 patients across a total of 20 study sites in
At the completion of the Phase 2 clinical study, all patients, irrespective of treatment group, had the option to receive treatment with ABP-450 by rolling over into a 52-week open-label extension study, and 51 of the 57 patients (89%) opted to do so.
To learn more about AEON and the development of its uniquely positioned therapeutic neurotoxin, visit www.aeonbiopharma.com.
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 and has an ongoing Phase 2 study of ABP-450 for the preventative treatment of both chronic and episodic 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 continued listing on the New York Stock Exchange 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 ability to continue to meet continued stock exchange listing standards; (iii) costs related to being a public company; (iv) changes in applicable laws or regulations; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (vi) AEON’s estimates of expenses and profitability; (vii) the evolution of the markets in which AEON competes; (viii) the ability of AEON to implement its strategic initiatives, including the continued development of ABP-450; (ix) the ability of AEON to defend its intellectual property; (x) the ability of AEON to satisfy regulatory requirements; (xi) the impact of the COVID-19 pandemic on AEON’s business; and (xii) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s prospectus and in subsequent 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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