AEON Biopharma Doses First Patient in Phase 2 Trial of ABP-450 for the Treatment of Cervical Dystonia
NEWPORT BEACH, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- 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 patient dosing in a Phase 2 study of ABP-450 for the treatment of cervical dystonia. The Company expects to announce topline data from the study in early-2022.
“The first patient dosed in our cervical dystonia study represents an important milestone as we advance our development programs for the therapeutic uses of ABP-450,” said Marc Forth, Chief Executive Officer of AEON Biopharma. “AEON’s therapeutic-only focus has allowed our experienced team to rapidly design and initiate multiple clinical studies targeting a number of debilitating medical conditions. Our pipeline was constructed to provide AEON with an efficient path to market, potential to deliver treatments to patients with unmet medical needs, and an ability to generate long term value by investing into programs with attractive regulatory risk profiles and significant commercial potential.”
Cervical dystonia is a rare neurological disorder characterized by involuntary muscle contractions of the neck which may present as spasms, contractions or abnormal postures of the head and neck. It is a chronic condition with no cure, causing pain and discomfort as well as 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.
The Phase 2 trial will evaluate the efficacy and safety of ABP-450 in adults with a clinical diagnosis of cervical dystonia. The Company expects the study to enroll 60 patients across approximately 32 sites in the United States. Study subjects will be divided evenly across four arms and receive a single treatment: a low dose group, a medium dose group, a high dose group, and a placebo group. The primary and secondary outcome measures are the safety and efficacy of a single treatment of ABP-450 compared to placebo four weeks after treatment. The primary efficacy endpoint is the mean reduction in TWSTRS (Toronto Western Spasmodic Toritcollis Rating Scale) total score at four weeks compared to baseline. Secondary efficacy endpoints include the mean score change on the Clinical Global Impression of Severity (CGI-S), Patient Global Impression of Severity (PGI-S), Clinical Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C).
Patients will be assessed by their treating investigator every two weeks and, provided they demonstrate sustained efficacy, will be followed for up to 20 weeks. At the end of the study, all patients will be eligible to enter into a 52-week open label extension to receive treatment with ABP-450. Patints assessed by their treating investigator at any time between week four and week 20 that demonstrate a loss or lack of efficacy will be eligible to discontinue the study and enter into the open label extension study.
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.
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.
This press release contains forward-looking statements including statements related to that safety and efficacy of ABP-450 for the treatment of cervical dystonia, 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.
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