AC Immune SA (NASDAQ:ACIU) revealed data from a Phase 2 clinical trial of its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate for early Parkinson's disease.
Dr. Andrea Pfeifer, CEO of AC Immune, commented: "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."
VacSYn is an adaptive, placebo-controlled, and biomarker-based Phase 2 study in patients with early PD, consisting of two parts.
Part 1 includes initial analyses from over 30 patients randomized to receive ACI-7104.56 or placebo.
To date, no clinically relevant safety issues have been reported other than transient injection site reactions (49%) and headaches (18%).
Interim results show positive antibody responses were effectively induced against the target antigen at week 6 after two immunizations and were strongly boostable.
Treatment with the candidate, ACI-7104.056, induced an increase in anti-a-syn antibodies on average 16-fold higher than the placebo background level after three immunizations.
Based on further interim results, including pharmacodynamic data, to be reported in H1 2025, AC Immune may decide to initiate Part 2 of VacSYn with up to 150 patients.
Patients from Part 2 will also be evaluated for the progression of motor and non-motor symptoms of the disease, as well as digital, imaging, and fluid biomarkers.
In May, Takeda Pharmaceutical Company Limited (NYSE:TAK) and AC Immune announced an exclusive, worldwide option and license agreement for AC Immune's active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for Alzheimer's disease.
Price Action: AC Immune stock is up 6.71% at $3.34 during the premarket session at last check Thursday.
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