AEON Biopharma, Inc. (AEON), a clinical-stage biopharmaceutical company, has presented positive Phase 2 results for ABP-450 in the treatment of cervical dystonia (CD) at the International Parkinson and Movement Disorders Society Congress (IP-MDS). CD is a chronic neurologic condition that affects the muscles of the neck, causing significant pain and disability.
The Phase 2 clinical study, conducted by AEON, evaluated the efficacy and safety of ABP-450 in adults with isolated cervical dystonia. The study included a total of 57 patients across 20 study sites in the United States. Patients were divided into four cohorts and received different doses of ABP-450 or a placebo. The primary efficacy endpoint was assessed at four weeks after dosing.
The results showed that the two lower doses of ABP-450 (150 units and 250 units) led to statistically significant improvements in the Toronto Western Spasmodic Torticollis rating scale (TWSTRS) total score from baseline to Week 4. The higher dose (350 units) also showed numerical improvement over placebo. Additionally, all doses of ABP-450 demonstrated sustained benefits, with the median duration of effect across all dosing arms lasting at least 20 weeks.
Improvements in Clinical Global Impression of Change and Patient Global Impression of Change scores were statistically significant in all three doses of ABP-450 compared to placebo at Week 4. The treatment was generally safe and well tolerated by patients with CD.
Marc Forth, AEON’s President and Chief Executive Officer, commented on the positive Phase 2 data, stating that they support the company’s strategy to pursue ABP-450 as an approved therapy for CD. AEON is now in discussions with the FDA regarding the design of a Phase 3 study in CD, which is expected to begin in 2024.
In addition to CD, AEON is also conducting a Phase 2 study of ABP-450 for the treatment of episodic migraine. The company anticipates announcing the topline data from this study in the fall of 2023.
ABP-450 is a botulinum toxin complex that blocks peripheral acetylcholine release, leading to muscle denervation and relaxation. It is manufactured by Daewoong and currently approved for cosmetic indications. AEON holds exclusive development and distribution rights for therapeutic indications of ABP-450 in several territories, including the United States and European Union.
The positive Phase 2 results for ABP-450 in the treatment of cervical dystonia bring hope for patients suffering from this debilitating condition. As AEON continues to advance the development of ABP-450, it is working towards providing a new treatment option for individuals living with CD.
