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.