According to a late September 2022 news release from biopharmaceutical company AEON Biopharma, Inc., positive topline data is available from a clinical trial evaluating ABP-450 for patients with cervical dystonia. Within the Phase 2 study, researchers sought to determine the safety, efficacy, and tolerability of ABP-450 for addressing cervical dystonia symptoms. 

ABP-450 (prabotulinumtoxinA) is administered via intramuscular injection. The treatment contains a 900 kDa botulinum toxin type-A complex, which is produced by Clostridium botulinum (C. botulinum). Licensed by AEON from Daewoong Pharmaceutical Co., ABP-450 cleaves a protein called SNAP-25, blocking the release of peripheral acetylcholine and allowing muscles to relax. Outside of cervical dystonia, ABP-450 is also being developed for a number of other conditions, including migraine conditions. 

Within this particular study, researchers administered either 150, 250, or 350 units of ABP-450, or a placebo, to enrolled participants. Altogether, fifty-seven individuals took part in this study, which included a 20-week follow-up period. Findings from the study include:

• ABP-450 was found to be relatively safe and well-tolerated. Some side effects did occur, which tended to be mild-to-moderate. These side effects included muscle weakness, torticollis, nausea, head pain or discomfort, injection site itching, general malaise, swollen joints, dizziness or lightheadedness, double vision, a flat red rash, and difficulty swallowing.
• The varied doses all helped to reduce symptoms related to cervical dystonia while improving patient quality-of-life (QOL). Both the 150 and 250 unit doses were found to show statistically significant benefit compared to the placebo. 
• Nearly 90% of patients enrolled in the trial chose to continue on to an open-label extension (OLE) trial.

What is Cervical Dystonia? 

Also known as spasmodic torticollis, cervical dystonia is a rare and chronic movement disorder characterized by involuntary muscle contractions. There are multiple other forms of dystonia which can affect different parts of the body. Cervical dystonia is considered focal, meaning it is localized to one area of the body (the neck). It can be either primary (without an underlying cause) or secondary. In secondary cervical dystonia, the condition may result from toxins, certain drug use, neck trauma, or degenerative brain diseases. The involuntary muscle contractions in the neck cause abnormal neck and head movements, which may cause awkward posture and other symptoms. Typically, this condition occurs in middle age. It is also 2x more common in women than men. Symptoms can include: 

• Abnormal head and neck movements and postures, such as:
  • Chin twisting towards a shoulder while rotating the head sideways (torticollis)
  • Ear twisting towards a shoulder 
  • Head tilting forward/backward/sideways
  • Ear twisting towards a shoulder
• Hand tremors
• Neck muscle enlargement
• Headache
• Intense neck pain and discomfort
• Cervical stenosis