-Clinical trial will enroll both episodic and chronic migraine patients-
-Protocol utilizes streamlined treatment paradigm with fewer injections-
-Topline data expected in mid-2022-
Newport Beach, Calif., March 8, 2021 – AEON Biopharma, Inc., a private clinical-stage biopharmaceutical company focused on the development of therapeutic indications for its proprietary botulinum toxin complex ABP-450 (prabotulinumtoxinA) injection, today announced the initiation of enrollment in a Phase 2 study of ABP-450 for the preventive treatment of migraine. The Company’s Investigational New Drug (IND) application for ABP-450 was accepted by the U.S. Food and Drug Administration in the fourth quarter of 2020.
Migraine is a complex neurological disease characterized by recurrent episodes of headaches that affects approximately 40 million people in the United States and approximately a billion people worldwide, making migraine the third most prevalent illness in the world1. Migraine is ranked globally as the seventh most disabling disease among all diseases and the leading cause of disability among all neurological disorders2. Patients that live with migraine experience symptoms that include recurring throbbing headache pain, nausea, vomiting, and sensitivity to light, sound, touch and smell. Chronic migraine is a sub-type of migraine that is characterized by 15 or more headache days a month. An estimated 2.2 million Americans are diagnosed with chronic migraine3. In addition, far more patients live with episodic migraine, which is characterized by fewer than 15 days per month, but each individual attack can be just as debilitating. The Company is enrolling both patient types in its Phase 2 program as described below.
“We are excited to initiate our lead development program to evaluate ABP-450 as a preventive treatment for chronic and episodic migraine and expect to announce topline data in mid-2022,” said Marc Forth, Chief Executive Officer of AEON Biopharma. “We believe ABP-450 could provide a differentiated treatment option for the millions of patients suffering from this disabling neurologic disease. Patients living with migraine and the health care professionals who serve them need therapeutic alternatives. We believe ABP-450 has the potential to be an important tool in the prevention of migraine. We continue to be encouraged by the progress of our clinical and pre-clinical development programs utilizing ABP-450 for the treatment of chronic medical conditions.”
The Phase 2 trial will evaluate the efficacy and safety of ABP-450 for migraine prevention in adults who suffer from six or more migraine days per month. The Company expects the study to enroll 690 patients across approximately 60 sites in the United States, Canada and Australia. Study subjects will be divided evenly across a low dose group receiving 150 units of ABP-450, a high dose group receiving 195 units of ABP-450, and a placebo group. All patients will receive two treatment cycles utilizing the Company’s novel treatment paradigm involving fewer injections than the current botulinum toxin treatment option for chronic migraine. The primary outcome measure is the change from baseline at six months in the mean number of migraine days per month. Secondary outcome measures include the achievement of at least a 50% reduction from baseline in mean monthly migraine days across the double-blind treatment phase and the mean number of rescue medication days per month, each as measured over the course of the double-blind, treatment phase.
Del Stagg, PhD, Vice President of Technical Operations and Regulatory, added, “We are encouraged by the safety and efficacy data that has been generated from multiple studies conducted by Daewoong with our botulinum toxin product, ABP-450. If our studies are successful and ABP-450 is approved for this indication, ABP-450 would represent a new treatment option for adults living with migraine. In addition, our novel injection paradigm, which is used in our clinical study protocol, is designed to streamline physician administration of ABP-450, while mitigating the risks for certain adverse events reporting following botulinum toxin treatment with other products.”
About ABP-450 (prabotulinumtoxinA) Injection
ABP-450 contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum. Botulinum toxin type-A specifically blocks the release of peripheral neurotransmitters and neuropeptide at presynaptic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of these substances from vesicles situated within the nerve endings. When used in the treatment of migraine, ABP-450 is injected into specific sites with the intent of mitigating the sensory input from peripheral nerves into the trigeminal-occipital-cervical complex by inhibiting the release of neuropeptides, including calcitonin gene-related peptide (CGRP), and neurotransmitters, including glutamate.
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 multiple registration studies of ABP-450 using BOTOX as an active comparator and consistently showed that ABP-450 was non-inferiority to Botox® in those studies at 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, Health Canada, MHRA and other regulatory agencies.
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 biopharmaceutical 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 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.
1 Migraine Research Foundation
2 Steiner TJ et al. Migraine: the seventh disabler. The Journal of Headache and Pain (2013)
3 Diamond et al. Patterns of Diagnosis and Acute and Preventive Treatment for Migraine in the United States: Results from the American Migraine Prevalence and Prevention Study. American Headache Society (2006)
This press release contains forward-looking statements including statements related to that safety and efficacy of ABP-450 for the treatment of migraine or other indications, announcement of results related to clinical trials, clinical trial site onboarding, patient recruitment into clinical trials, and any future development efforts. 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
Corey Davis, Ph.D.
+1 212 915 2577