An early-stage Parkinson’s vaccine called ACI-7104 has shown positive interim safety and immunogenicity data from a Phase 2 clinical trial.
The vaccine is an active immunotherapy which has generated a target-specific antibody response against pathological oligomeric alpha-synuclein to inhibit spreading and downstream neurodegeneration in early Parkinson’s disease.
The accumulation of alpha-synuclein (a-syn) protein aggregates has been shown to cause inflammatory stress in cells and contribute to the degeneration of neurons in the brain and is known to play a key role in the development of neurodegenerative diseases such as Parkinson’s Disease.
Previous clinical studies showed the predecessor candidate produced a strong and boostable antibody response with evidence of target engagement and a signal of clinical efficacy according to developers C Immune SA.
To date, no clinically relevant safety issues have been reported other than transient injection site reactions (49 per cent) and headaches (18 per cent).
Interim results show positive antibody responses were effectively induced against the target antigen at week six after two immunisations and were boostable. Treatment with ACI-7104 induced an increase in anti-a-syn antibodies on average 16-fold higher than the placebo background level after three immunisations.
“We are encouraged by these initial Phase 2 safety and immunogenicity data on our ACI-7104.056 active immunotherapy being studied in early Parkinson’s disease,” Dr. Andrea Pfeifer, CEO of AC Immune SA, commented.
“The level of immunogenicity after only three months of treatment as well as the continued positive safety profile, reinforces the best-in-class characteristics of our clinically validated anti-a-syn active immunotherapy for the treatment of Parkinson’s disease.
“We look forward to sharing further updates in H1 2025 including the decision to expand into Part 2 of the VacSYn study.”
Further interim results are expected to be reported in 2025 including pharmacodynamic data. Patients from Part 2 of the study will also be evaluated for progression of motor and non-motor symptoms of the disease, as well as digital, imaging, and fluid biomarkers.
The aim is to establish early proof-of-concept and identification of disease-specific biomarkers for rapid transition into a pivotal study.
