Core Insights - AC Immune SA announced positive interim results from the Phase 2 VacSYn trial for ACI-7104.056, an active immunotherapy targeting alpha-synuclein in early Parkinson's disease, indicating potential to slow disease progression [2][4][11] Interim Results - The VacSYn trial is a placebo-controlled, biomarker-based Phase 2 study involving 34 patients, with all participants treated for at least 12 months [5] - Interim results demonstrated that all target criteria for immunogenicity were met, with a 100% responder rate and a clear safety profile [6][10] - Antibody titers in serum were over 500-fold higher in the treatment group compared to placebo, indicating a robust immune response [7][8] Biomarker and Clinical Assessments - Disease-related biomarkers showed stabilization in the treatment group, including total CSF alpha-synuclein levels and neurofilament light chain (NfL) [12] - Clinical measures indicated a trend for stabilization of motor symptoms in the active treatment group, with no meaningful progression in MDS-UPDRS Part III scores [9][12] Expert Commentary - Dr. Andrea Pfeifer, CEO of AC Immune, emphasized the potential of ACI-7104.056 to transform Parkinson's disease treatment based on the interim data [4] - Dr. Werner Poewe highlighted the promising consistency of trends across multiple biomarkers and clinical assessments, suggesting beneficial effects on disease progression [4] Future Development Plans - Based on the interim results, AC Immune plans to seek regulatory feedback to accelerate the clinical development plan towards registration [11] - Final data from Part 1 of the VacSYn trial is expected in mid-2026 [11]

Core Insights - AC Immune SA announced further positive interim results from the Phase 2 VacSYn clinical trial for ACI-7104.056, an active immunotherapy for early Parkinson's disease, highlighting safety and immunogenicity data [1][2] Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision therapeutics for neurodegenerative diseases, including Alzheimer's and Parkinson's disease [6] - The company utilizes two clinically validated technology platforms, SupraAntigen® and Morphomer®, to develop a diversified pipeline of therapeutic and diagnostic programs [6] Clinical Trial Details - The VacSYn trial is an adaptive, placebo-controlled, biomarker-based Phase 2 study involving over 30 patients, with a treatment ratio of 3:1 for ACI-7104.056 versus placebo [2][4] - No serious adverse events related to the study drug have been reported, with mild and transient injection site reactions and headaches being the most common adverse events [2][7] Immunogenicity Results - Interim results indicate that ACI-7104.056 induced a more than 20-fold increase in anti-alpha-synuclein antibodies compared to placebo after four immunizations [3][7] - The antibody response was effectively boosted with each additional immunization, supporting the potential for increased antibody titers [7] Future Plans - Based on further interim results expected later in 2025, AC Immune may initiate Part 2 of the VacSYn trial with up to 150 patients, focusing on the progression of motor and non-motor symptoms and identifying disease-specific biomarkers [4]

Core Insights - AC Immune SA announced positive interim results from the Phase 2 VacSYn clinical trial for ACI-7104.056, an active immunotherapy for early Parkinson's disease, highlighting its safety and immunogenicity [2][3][4] Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision therapeutics for neurodegenerative diseases, including Alzheimer's and Parkinson's disease [7] - The company utilizes two technology platforms, SupraAntigen® and Morphomer®, to develop a diversified pipeline of therapeutic and diagnostic programs [7] Clinical Trial Details - The VacSYn trial is a placebo-controlled, biomarker-based study involving over 30 patients, with a treatment ratio of 3:1 for ACI-7104.056 versus placebo [3][5] - No serious adverse events related to the study drug have been reported, with mild and transient injection site reactions and headaches being the most common adverse events [3][8] Immunogenicity Results - Interim results indicate that ACI-7104.056 induced a more than 20-fold increase in anti-alpha-synuclein antibodies compared to placebo after four immunizations [4][8] - The antibody response was effectively boosted with each additional immunization, supporting the potential for increased antibody titers [8] Future Plans - Based on further interim results expected later in 2025, AC Immune may initiate Part 2 of the VacSYn trial with up to 150 patients, focusing on the progression of motor and non-motor symptoms and identifying disease-specific biomarkers [5]