Topline data expected to be announced in the second half of 2022
Newport Beach, Calif., April 11, 2022 – AEON Biopharma, Inc. (“AEON” or the “Company”), a private clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex ABP-450 (prabotulinumtoxinA) injection for therapeutic indications, today announced the completion of patient enrollment in the Phase 2 clinical study of ABP-450 (prabotulinumtoxinA) for the treatment of cervical dystonia. The Company expects to announce topline data from the study in the second half of 2022.
“We are excited to report that our Phase 2 clinical study of ABP-450 for the treatment of cervical dystonia continues to advance, and we look forward to announcing topline data in the second half of 2022,” said Marc Forth, Chief Executive Officer of AEON. “If approved, ABP-450 will be the only therapeutic botulinum toxin physiochemically similar to Botox. Paired with our anticipated reimbursement benefits, this would be a significant opportunity, as we estimate the addressable market for treating the cervical dystonia patients in the U.S. alone to be approximately $360 million.”
The Phase 2 randomized, double-blind, placebo-controlled study enrolled a total of 59 patients across a total of 25 study sites in the United States. Patients enrolled into the clinical study are divided evenly across four cohorts, including a low dose (150 units), mid-dose (250 units), high dose (350 units), and placebo. Each patient receives a single treatment cycle of their designated dose of ABP-450 or placebo. Due to the nature of the disease, dosing in initial sessions is tailored to the individual patient based on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. The primary endpoint of the clinical study is to evaluate the safety of a single treatment of ABP-450 over a maximum of 20 weeks. The secondary endpoint is the mean difference of change from baseline to week four of each dosing cohort, as measured on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), the standard scale for measuring the severity of cervical dystonia. At the completion of the Phase 2 clinical study, all patients, irrespective of treatment group, will have the option to receive treatment with ABP-450 by rolling over into a 52-week open-label extension study.
About Cervical Dystonia
Cervical dystonia, also known as spasmodic torticollis, is a neurological condition characterized by involuntary muscle contractions of the neck, which may present as spasms, contractions or abnormal posture. It is a chronic condition with no cure, causing significant pain and challenges to mobility due to abnormal postures, affecting quality of life and daily activities. Botulinum toxin is the standard of care for the treatment of cervical dystonia, helping to improve pain, posture, and disability. Based on U.S. census data and published clinical studies, the Company estimates there are approximately 50,000 addressable cervical dystonia patients in the United States, of which 30,000 are currently treated.
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.
AEON licenses ABP-450 from Daewoong and possesses exclusive development and distribution rights for its therapeutic indications in the United States, Canada, the European Union, and certain other international territories. To produce ABP-450, Daewoong constructed a facility in South Korea, purpose- built to comply with FDA and EMA regulations, and continues to expand its production capacity. ABP- 450 is the same botulinum toxin complex that has been approved by regulatory authorities in the United States, the European Union and Canada for an aesthetic indication and has consistently shown to be non-inferior to Botox® at doses ranging from 20 units to 360 units.
About AEON Biopharma
AEON is a clinical stage biopharmaceutical company focused on developing ABP-450 (prabotulinumtoxinA) injection for the treatment of debilitating medical conditions with an initial focus on the neurology and gastroenterology markets. The Company is dedicated to innovation in the rapidly expanding therapeutic botulinum toxin market and believes its therapeutic-only focus will allow AEON to advance safe and effective treatment options to patients, while delivering differentiated economics to payors and physicians. The Company continues to evaluate additional therapeutic indications for development based on a comprehensive product assessment process designed to identify those indications where it believes ABP-450 can attain clinical, regulatory, and commercial success. More information about AEON can be found at www.aeonbiopharma.com.
This press release contains forward-looking statements that are based on management’s believe and assumptions and on information currently available to management. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. All statements other than statements of historical fact could be deemed forward-looking, including any statements about current or planned clinical trials or related milestones; any projections of financial information; any statements about historical results that may suggest trends for the Company’s business; any statements of the plans, strategies, and objectives of management for future operations; any statements of expectation or belief regarding future events, potential markets or market size, or technology developments; and any statements of assumptions underlying any of the items mentioned. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control. These and other important factors may cause actual results, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof. Except as required by law, the Company assumes no obligation and does not intend to update these forward-looking statements or to conform these statements to actual results or to changes in the Company’s expectations.
AEON Biopharma, Inc. Contacts:
Chris Carr, AEON Biopharma Chief Financial Officer
+1 949 354 6439 [email protected]
Corey Davis, Ph.D.
+1 212 915 2577 [email protected]