AEON Biopharma Doses First Patient in Phase 2 Trial of ABP-450 for the Treatment of Cervical Dystonia
AEON Biopharma, Inc. recently 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 US. 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 2 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. Patients 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.
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 US, 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 US, Canada, the European Union, inclusive of the United Kingdom, and certain other international territories.
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. For more information, visit www.aeonbiopharma.com.
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