AC Immune Reports Positive Results for ACI-7104.056 Clinical Trial
AC Immune announced positive interim safety and efficacy results from the Phase 2 VacSYn trial of its wholly-owned anti-alpha-synuclein active immunotherapy ACI-7104.056 in early Parkinson's disease, or PD. Results show, for the first time, that targeting a-syn pathology with an active immunotherapy could potentially slow the rate of progression of PD. Disease-related biomarker results suggest stabilization of PD pathology. In addition, total scores are suggestive of a trend for stabilization. Interim results showed all target criteria for immunogenicity were met, including: ACI-7104.056 induced a robust antibody response against the immunizing a-syn target antigen with a 100% responder rate; titers against the immunizing a-syn target antigen increased with successive immunizations, showing ACI-7104.056 generates antibodies that cross the blood-brain barrier. The stabilization of disease-relevant biomarkers in the central nervous system, suggests slowing of Parkinson's disease pathology, with potential disease modification. Levels of Neurofilament Light chain in the CSF remained stable in the ACI-7104.056 group and increased in the placebo group. Stabilization suggests a potential slowing of neuronal damage. Interim results from weeks 50 and 76 continue to demonstrate that ACI-7105.056 is generally safe and well-tolerated enabling a positive benefit/risk ratio. AC Immune aims to seek regulatory feedback on an ACI-7104.056 clinical development plan to potentially accelerate towards registration. Final data from Part 1 of the VacSYn trial are expected in mid-2026.
Trade with 70% Backtested Accuracy
Analyst Views on ACIU
About ACIU
About the author
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.
