AC Immune has announced additional interim safety and immunogenicity results from its placebo-controlled Phase II VacSYn trial of ACI-7104.056, an anti-alpha-synuclein active immunotherapy designed for early Parkinson’s disease (PD). The adaptive, biomarker-driven study includes two parts. Part 1 enrolled over 30 participants, randomized 3:1 to receive either ACI-7104.056 or placebo. Interim data showed strong immune responses, with antibody levels increasing over 20-fold above placebo following four immunisations. These findings suggest a robust immunogenic effect against the targeted alpha-synuclein protein.
Pending further interim results—including biomarker and pharmacodynamic data—AC Immune may proceed with Part 2 of the trial, expanding enrollment to up to 150 patients. This next phase will assess motor and non-motor symptom progression and utilize imaging, fluid, and digital biomarkers. The company aims to establish early proof-of-concept and identify disease-specific biomarkers to accelerate progression to a pivotal trial. These promising results highlight ACI-7104.056’s strong safety profile and potential as a best-in-class PD therapy.
03-04-2025