Groundbreaking Study in Nature Communications Reveals Potential of AC Immune's ACI-19626 as a TDP-43 PET Tracer for Precision Medicine
TDP-43 PET Tracer Development: AC Immune SA has published preclinical data on ACI-19626, a first-in-class PET tracer for imaging TDP-43 pathology, which is significant for diagnosing neurodegenerative diseases like ALS, FTD, and Alzheimer's.
Clinical Trial Progress: ACI-19626 has shown high specificity and sensitivity in detecting TDP-43 aggregates and is currently advancing into a Phase 1 clinical study, with initial results expected in Q4 2025.
Potential Impact on Diagnosis and Treatment: The ability to accurately image TDP-43 pathology could enhance differential diagnosis and facilitate earlier therapeutic interventions, potentially transforming the management of neurodegenerative diseases.
Company Background: AC Immune is a clinical-stage biopharmaceutical company focused on precision prevention for neurodegenerative diseases, leveraging its proprietary technology platforms to develop innovative therapeutic and diagnostic solutions.
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AC Immune Study Indicates Promising Early Results for Immunotherapy in Slowing Parkinson's Disease
Interim Results from VacSYn Trial: AC Immune SA reported promising interim safety and efficacy results from its Phase 2 VacSYn trial for the anti-alpha-synuclein immunotherapy ACI-7104.056, indicating potential slowing of Parkinson's disease progression through stabilization of disease-related biomarkers.
Robust Antibody Response: The treatment induced a strong antibody response against the target antigen, with a 100% responder rate and significantly higher antibody levels in both serum and cerebrospinal fluid compared to the placebo group.
Clinical Measures of Stabilization: Clinical assessments showed that the ACI-7104.056 group did not experience meaningful progression in motor symptoms, contrasting with the expected increase in the placebo group, suggesting a trend toward disease stabilization.
Future Expectations: The trial results are generally safe and well-tolerated, with final data from Part 1 of the VacSYn trial anticipated in mid-2026, while AC Immune's stock saw a notable increase following the announcement.
AC Immune's ACI-7104.056 Significantly Slows Parkinson's Disease Progression
- Clinical Trial Success: AC Immune's Phase 2 VacSYn trial of ACI-7104.056 demonstrates, for the first time, that targeting alpha-synuclein pathology with active immunotherapy may slow the progression of Parkinson's disease, marking a significant breakthrough in treatment.
- Strong Safety Profile: The therapy was administered to 34 patients, all treated for at least 12 months, with no clinically relevant adverse events reported, indicating a favorable safety and tolerability profile.
- Robust Immune Response: By week 76, the ACI-7104.056 group exhibited antibody titers over 500 times higher than the placebo group, achieving a 100% responder rate, showcasing the therapy's potential to induce a strong immune response and laying the groundwork for future treatments.
- Stabilization of Biomarkers: The treatment group showed stable levels of neurofilament light chain (NfL), a marker of neuronal damage, while levels increased in the placebo group, suggesting that the therapy may effectively slow neuronal damage, which has significant clinical implications.
