Daewoong Pharmaceutical announced on Jan. 30 that its partner, AEON Biopharma, presented the Phase 2 clinical trial results and preclinical PTSD data of Daewoong’s botulinum toxin ABP-450 at the TOXINS 2024 conference. TOXINS 2024, a significant conference on neurotoxins, took place in Berlin, Germany, from Jan. 17 to 20. AEON Biopharma, a partner company contracted with Daewoong Pharmaceutical in 2019 for the global treatment business of botulinum toxin formulations, is currently conducting clinical trials for ABP-450’s therapeutic indications in the United States.
AEON Biopharma presented the results of the “Efficacy and Safety of ABP-450: An Open Label Extension Study of a Phase 2 Clinical Trial” for patients with cervical dystonia. The previous placebo-controlled, double-blind Phase 2 trial confirmed the safety and pain improvement effectiveness of ABP-450 over a 20-week treatment period for cervical dystonia. The open-label extension study further examined the long-term safety and effectiveness of repeated doses of ABP-450 over 52 weeks in adults with moderate to severe cervical dystonia.
The dosages in the extension study ranged from 115 to 350 units. The maximal effect of all doses and intervals of ABP-450 was observed within the first four weeks, similar to the initial Phase 2 trial, with sustainability of the effect lasting 12-16 weeks post-treatment. The study’s significance lies in its demonstration of safety, as no increase in adverse events was observed despite long-term repeated dosing.
Based on these positive Phase 2 results, AEON Biopharma plans to discuss the design of the forthcoming Phase 3 clinical trials with the U.S. Food and Drug Administration.