AEON Biopharma, Inc. announced the presentation of positive results from its Phase 2 clinical study of ABP-450 for the treatment of cervical dystonia (CD), a chronic and debilitating neurologic condition affecting the muscles of the neck, at the International Parkinson and Movement Disorders Society Congress (IP-MDS), which is being held at the Bella Center in Copenhagen, Denmark, from August 27 ? 31, 2023. The data was previously released by the Company in September 2022.

The poster titled, A Phase 2, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of ABP-450 (PrabotulinumtoxinA) in Adults With Isolated Cervical Dystonia,?was presented by Chad Oh, the Company?s Chief Medical Officer. The poster reports on the full data from the Phase 2 study, which demonstrate that the two lower doses (150 units and 250 units) of ABP-450 led to statistically significant improvements in Toronto Western Spasmodic Torticollis rating scale (TWSTRS) total score from baseline to Week 4, while the higher dose (350 units) showed numerical improvement over placebo. All doses of ABP-450 in the study demonstrated relatively sustained benefits, with the median duration of effect across all dosing arms of at least 20 weeks, patients?

last visit. At Week 4, improvement in Clinical Global Impression of Change and Patient Global Impression of Change scores were statistically significant in all three doses of ABP-450 compared with placebo. ABP-450 was generally safe and well tolerated by patients with CD.

The Phase 2 trial is a randomized, double-blind, placebo-controlled study that analyzed a total of 57 patients across a total of 20 study sites in the United States. Patients were divided evenly across four cohorts, including a low dose (150 units), mid-dose (250 units) and high dose (350 units) treatment of ABP-450, and placebo. Each patient received a single treatment cycle of their designated dose of ABP-450 or placebo.

Patients were followed up to a total of 20 weeks, and the primary efficacy endpoint was assessed at four weeks after dosing. Due to the nature of the disease, dosing is tailored to the individual patient by the investigator based on the severity of the patient?s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. At the completion of the Phase 2 clinical study, all patients, irrespective of treatment group, had the option to receive treatment with ABP-450 by rolling over into a 52-week open-label extension study, and 51 of the 57 patients (89%) opted to do so.

ABP-450 contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum. The active part of the botulinum toxin is the 150 kDa component, and the remaining 750 kDa of the complex is made up of accessory proteins that the Company believes help with the function of the active portion of the botulinum toxin. When injected at therapeutic levels, ABP-450 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.