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Edge12 Dec 2025
Running on Clouds: The Story of On
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AC Immune (ACIU) investor relations material
AC Immune Study Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study Update summary11 Dec, 2025
Study design and objectives
Phase 2 trial of ACI-7104, an anti-alpha-synuclein active immunotherapy, in early Parkinson's disease, focused on safety, tolerability, immunogenicity, pharmacodynamics, and biomarker measures.
Adaptive, biomarker-based, placebo-controlled design with interim analyses for safety, immunogenicity, and biomarker response.
34 subjects with early idiopathic Parkinson's disease, aged 40–75, Hoehn and Yahr stage 1 or 2, enrolled across 12 sites.
Inclusion criteria: early PD (≤2 years from motor symptom onset), ages 40–75.
Interim analysis not powered for active vs. placebo comparison but focused on trends and safety.
Safety and tolerability
No clinically relevant or serious adverse events related to ACI-7104 observed; most common adverse events were mild and transient, including injection site reactions, headache, and fatigue.
No significant MRI, lab, or ECG abnormalities reported.
Immunogenicity and antibody response
100% responder rate for anti-alpha-synuclein antibodies in serum, with robust, boostable, and sustained titers up to week 76.
Antibody titers in both serum and CSF increased with successive immunizations, showing strong correlation and over 500-fold increase from baseline.
Basis for accelerated regulatory pathway
Strength of biomarker-clinical correlation
ACI-7104.056's differentiation in PD therapy
ACI-7104 accelerated development pathway details
ACI-7104 impact on specific alpha-synuclein species
ACI-7104 long-term dosing strategy considerations
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Q4 202513 Mar, 2026
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Frequently asked questions
AC Immune SA is a clinical-stage biopharmaceutical company that specializes in precision medicine for neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and NeuroOrphan diseases. These candidates target the misfolded proteins associated with these diseases, aiming to diagnose, treat, and prevent neurodegeneration. AC Immune SA is headquartered in Lausanne, Switzerland, and its shares are listed on the Nasdaq.
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