AEON Biopharma Presents Positive Results from Phase 2 Clinical Trial of ABP-450 (prabotulinumtoxinA) in Cervical Dystonia at the International Parkinson and Movement Disorders Society Congress®
- Positive Phase 2 results for ABP-450 in cervical dystonia
- Lower doses showed significant improvements in TWSTRS scores
- Median duration of effect at least 20 weeks
- FDA discussions for Phase 3 study underway
- Topline data for Phase 2 study in episodic migraine to be announced in fall 2023
- None.
IRVINE, Calif., Aug. 29, 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 the presentation of positive results from its Phase 2 clinical study of ABP-450 for the treatment of cervical dystonia (CD), a chronic and debilitating neurologic condition affecting the muscles of the neck, at the International Parkinson and Movement Disorders Society Congress® (IP-MDS), which is being held at the Bella Center in Copenhagen, Denmark, from August 27 – 31, 2023. The data was previously released by the Company in September 2022.
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 Chad Oh, the Company’s Chief Medical Officer. The poster reports on the full data from the Phase 2 study, which demonstrate that the two lower doses (150 units and 250 units) of ABP-450 led to statistically significant improvements in Toronto Western Spasmodic Torticollis rating scale (TWSTRS) total score from baseline to Week 4, while the higher dose (350 units) showed numerical improvement over placebo. All doses of ABP-450 in the study demonstrated relatively sustained benefits, with the median duration of effect across all dosing arms of at least 20 weeks, patients’ last visit. At Week 4, improvement in Clinical Global Impression of Change and Patient Global Impression of Change scores were statistically significant in all three doses of ABP-450 compared with placebo. ABP-450 was generally safe and well tolerated by patients with CD.
“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 Marc Forth, AEON’s President and Chief Executive Officer. “We look forward to advancing the development of ABP-450 as a treatment option for patients living with this debilitating condition. Currently, we are in discussions with the FDA regarding the design of a Phase 3 study in CD, which we expect to commence in 2024 based on the availability of capital resources. In addition, we are on track to announce the topline data from our ongoing Phase 2 study of ABP-450 in episodic migraine in fall of 2023.”
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 the United States. Patients were divided evenly across four cohorts, including a low dose (150 units), mid-dose (250 units) and high dose (350 units) treatment of ABP-450, and placebo. Each patient received a single treatment cycle of their designated dose of ABP-450 or placebo. Patients were followed up to a total of 20 weeks, and the primary efficacy endpoint was assessed at four weeks after dosing. Due to the nature of the disease, dosing is tailored to the individual patient by the investigator based on the severity of the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history.
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 (
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 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.
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 Securities and Exchange Commission.
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
