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AC Immune Reports Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson’s Disease
AC Immune Reports Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson’s Disease Active immunotherapy with
About this update from Ac Immune Sa
[{"type":"text","content":"AC Immune Reports Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson’s Disease Active immunotherapy with ACI-7104.056 induces high anti-a-synuclein antibody levels on average 16-fold higher than placebo after 3 immunizations100% of patients receiving ACI-7104.056 responded against the target antigenACI-7104.056 is well tolerated with no clinically relevant safety issues reported to date Lausanne, Switzerland, November 14, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced positive interim safety and immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson’s disease (PD). Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “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. The level of immunogenicity after only 3 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.” Dr. Pfeifer added, “As a leader in active immunotherapies for neurodegenerative diseases with two FDA Fast Track designated candidates, an important recognition of their promise, we are delighted with these initial VacSYn data. They further support the approach of using active immunotherapies to target the hallmark pathological proteins of neurodegenerative diseases, such as a-synuclein in Parkinson’s disease, before irreversible damage occurs.” VacSYn is an adaptive, placebo-controlled, and biomarker-based Phase 2 study in patients with early PD, consisting of two parts with a seamless transition. Part 1 includes initial analyses from over 30 patients randomized to receive ACI-7104.56 or placebo at a ratio of 3:1. To date, no clinically relevant safety issues have been reported other than transient injection site reactions (49%) and headaches (18%). Interim results show po...