-Critical milestone transitions AEON Biopharma to clinical-stage company-
-Moving directly into Phase 2 clinical trial expected to begin in the first half of 2021-
-Investment expected to provide funding for clinical programs into 2021-
Newport Beach, Calif., September 2, 2020 – AEON Biopharma, Inc., a private biotechnology company focused on the development of therapeutic indications for its proprietary botulinum toxin complex ABP-450 (prabotulinumtoxinA) injection, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ABP-450 to treat cervical dystonia. Cervical dystonia 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. It is estimated that approximately 50,000 people suffer from cervical dystonia in the United States and the standard of care for these cervical dystonia patients is treatment with botulinum toxin injections.
“The FDA’s permission to begin human testing with a Phase 2 trial in patients is a significant first step in the development of our therapeutic botulinum toxin portfolio,” said Marc Forth, Chief Executive Officer of AEON Biopharma. “We believe that AEON will be uniquely capable of safely treating patients afflicted by cervical dystonia, while leveraging our therapeutic-only focus to provide needed competition that will benefit physicians and patients. We intend to build on this IND acceptance by continuing to pursue additional therapeutic indications for our well-established neurotoxin, ABP-450.”
AEON Biopharma also announced that its strategic partner, Daewoong Pharmaceutical Co., Ltd., will invest $25 million in the company in the form of a 5-year, unsecured, subordinated, 3% convertible note. This convertible note will automatically convert into 9.99% of the company’s common stock immediately prior to an initial public offering, subject to the terms and conditions of the definitive agreement.
“This investment signals our strategic partner’s long-term commitment to AEON Biopharma and the U.S. therapeutic neurotoxin market and is expected to provide sufficient capital to enable the expansion of our clinical development programs into 2021,” said Chris Carr, Chief Financial Officer of AEON Biopharma.
About ABP-450 (prabotulinumtoxinA) Injection
ABP-450 contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum. When injected at therapeutic doses, ABP-450 causes a chemical denervation of the muscle resulting in localized reduction of muscle activity. Botulinum toxin type-A specifically 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.
ABP-450 is the same botulinum toxin complex that has been approved in the United States, the European Union and Canada for an aesthetic indication. To support this aesthetic indication, Daewoong’s aesthetic partner completed a Phase 3 head-to-head study with ABP-450 that showed non-inferiority to Botox® at 20 units. Daewoong has also completed head-to-head studies with ABP-450 that showed non-inferiority to Botox® at various doses ranging from 20 units to 360 units. Daewoong has also demonstrated validated chemistry and manufacturing and controls that it believes are sufficient to manufacture ABP-450 at scale in connection with regulatory approval by FDA, European Medicines Agency and Health Canada.
AEON Biopharma licenses ABP-450 from Daewoong and possesses exclusive development and distribution rights for ABP-450 for therapeutic indications in the United States, Canada, the European Union, inclusive of the United Kingdom, and certain other international territories.
About AEON Biopharma
AEON Biopharma is a bio-pharmaceutical company focused on developing ABP-450 (prabotulinumtoxinA) injection for the treatment of debilitating medical conditions. The company is dedicated to innovation in the rapidly expanding therapeutic botulinum toxin market. This therapeutic-only focus will allow AEON Biopharma to advance safe and effective treatment options to patients, while delivering differentiated economics to payers 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 including statements related to that safety and efficacy of ABP-450 for the treatment of cervical dystonia or other indications, future development efforts, the projected start date of clinical trials for ABP-450, and the completion of the financing by Daewoong. 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.
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