AC Immune announced positive interim Phase 2 trial results for ACI-7104.056, an active immunotherapy targeting alpha-synuclein (a-syn) in early Parkinson’s Disease. The therapy induced high anti-a-syn antibody levels, over 20 times higher than placebo, after four immunizations, with repeated doses amplifying the antibody response. Importantly, ACI-7104.056 has been well-tolerated with no reported safety concerns.
This news is particularly encouraging for Parkinson’s disease research as it suggests a potential new therapeutic avenue. Current treatments primarily address symptoms, not the underlying disease pathology. Targeting a-syn, a protein implicated in Parkinson’s progression, represents a disease-modifying approach that could slow or even halt disease progression. The boostable antibody response further enhances the therapeutic potential, allowing for dose adjustments to maximize efficacy.
The Phase 2 VacSYn trial involved over 30 early-stage Parkinson’s patients, randomized 3:1 to ACI-7104.056 or placebo. Interim analysis revealed no serious adverse events related to the drug, with mostly mild injection site reactions and headaches. The significant increase in anti-a-syn antibodies following immunization suggests effective target engagement. Pending further pharmacodynamic and biomarker data expected later in 2025, AC Immune may initiate the second part of the VacSYn trial, expanding to 150 patients and including exploratory endpoints related to motor and non-motor symptom progression.
The positive interim results position ACI-7104.056 as a promising candidate for Parkinson’s disease. The therapy’s apparent safety profile and ability to generate a robust and boostable immune response against a-syn offer hope for a disease-modifying treatment. The upcoming data readout later in 2025 will be crucial for validating these early findings and informing the next stage of clinical development. Positive results from the expanded trial could significantly advance the treatment landscape for Parkinson’s disease, potentially offering a new and effective option for patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
