In a notable development, AEON Biopharma, Inc. (NYSE: AEON) saw a significant increase in its stock value, climbing 32.08% to close the week at $1.40 per share. This surge followed the company’s announcement of plans to initiate a pivotal clinical study for its leading candidate, ABP-450 injection, aimed at treating cervical dystonia (CD). AEON Biopharma is pursuing approval via the 351(k) regulatory pathway for biosimilars, referencing the market leader, BOTOX.
Regulatory and Clinical Development Plans
In its comprehensive submission to the FDA, AEON Biopharma included extensive data from analytical, pharmacological, and animal studies to support a forthcoming Biologics License Application (BLA).
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A successful Phase 3 comparative study in CD could potentially yield the clinical data necessary to demonstrate that ABP-450 is highly similar to BOTOX, supporting approval for all existing and future therapeutic indications. AEON Biopharma’s strategy is to bring ABP-450 to the U.S. market through a single approval process by conducting one comparative study.
Future Prospects and Clinical Trials
AEON Biopharma is set to discuss its plans with the FDA during a Biosimilar Initial Advisory Meeting in the third quarter. ABP-450, which has the same 900kDa molecular weight as BOTOX, has already undergone extensive analytical and preclinical testing.
Following the upcoming FDA meeting, AEON Biopharma plans to advance to a Phase 3 CD study with approximately 400 patients, comparing ABP-450 directly to BOTOX to establish non-inferiority, forming the basis for a BLA filing. The Phase 2 clinical trial results for ABP-450 in the treatment of CD were released by AEON Biopharma in September 2022.
These results were presented at the International Parkinson and Movement Disorders Society Congress (IP-MDS) in August 2023. 57 patients from 20 different U.S. sites participated in the randomized, double-blind, placebo-controlled research, with the primary effectiveness objective being evaluated four weeks after dosage. The Toronto Western Spasmodic Torticollis Rating Scale demonstrated statistically significant improvements for the lower dosages of ABP-450, according to the data.
