AEON Biopharma Announces Strategic Reprioritization to Pursue a Biosimilar Pathway for ABP-450

Core Insights - AEON Biopharma plans to conduct a pivotal Phase 3 study comparing its lead candidate ABP-450 to BOTOX® for cervical dystonia, utilizing the 351(k) biosimilar pathway following an FDA meeting in Q3 2024 [1][2] - The company aims to demonstrate that ABP-450 is highly similar to BOTOX® across all currently approved and future therapeutic indications through a single comparative study [2] Company Overview - AEON Biopharma is a clinical-stage biopharmaceutical company focused on developing ABP-450 (prabotulinumtoxinA) for various therapeutic indications, initially targeting the neurosciences market [4] - ABP-450 shares the same molecular weight as BOTOX® at 900kDa and has undergone extensive analytical and preclinical testing, much of which is already completed [2] - The company has exclusive development and distribution rights for ABP-450 in the U.S., Canada, EU, UK, and other territories, and the product is already approved as a biosimilar in Mexico and India [4] Clinical Trial Details - The Phase 2 clinical trial of ABP-450 for cervical dystonia involved 57 patients across 20 sites in the U.S., with results presented at the IP-MDS Congress in August 2023 [3] - The trial demonstrated statistically significant improvements in the Toronto Western Spasmodic Torticollis rating scale (TWSTRS) total score for the lower doses of ABP-450, with improvements of 14.01 points (p=0.007) for 150 units and 11.28 points (p=0.0406) for 250 units [3] - All dosing arms showed sustained benefits, with a median duration of effect of at least 20 weeks [3]