1. AC Immune reports positive Phase 2 data for ACI-7104.056. 2. Immunotherapy may slow progression of Parkinson’s disease. 3. Safety profile remains strong with no relevant adverse events. 4. Key biomarkers show stabilization of Parkinson’s pathology. 5. Conference call scheduled for further discussion on data.
FAQ
Why Bullish?
The positive interim results indicate significant potential for ACI-7104.056. Historical examples show price increases following favorable trial data announcements.
How important is it?
The article discusses pivotal clinical trial results for ACI-7104.056. Its implications for Parkinson’s treatment could significantly impact ACIU's market position and valuation.
Why Long Term?
If ongoing development and registration succeed, ACIU may achieve sustained market advantages. Similar past cases, like Biogen's aducanumab, demonstrated long-term market benefits from positive clinical trials.
Positive Interim Phase 2 Results for ACI-7104.056 Indicate Potential to Slow Parkinson’s Disease Progression
AC Immune SA (NASDAQ: ACIU), a biopharmaceutical firm dedicated to developing precision therapeutics for neurodegenerative diseases, announced positive interim data from the Phase 2 VacSYn trial of its active immunotherapy, ACI-7104.056, designed for early-stage Parkinson’s disease (PD). The trial's results suggest that this innovative treatment may effectively slow the rate of progression associated with PD.
Key Study Findings
The interim results reveal several promising outcomes, including:
- Safety Profile: No clinically relevant safety issues were reported, indicating a favorable safety profile.
- Immunogenicity: ACI-7104.056 achieved a 100% responder rate among participants, demonstrating a robust immunological response.
- Clinical Assessment: Clinical scores, as measured on Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), suggest stabilization in the treatment group.
Implications for Parkinson's Disease Treatment
Dr. Andrea Pfeifer, CEO of AC Immune, expressed optimism about the trial's findings, stating, “The consistent signs of efficacy, combined with the continuing strong safety record, underline ACI-7104.056’s potential to transform PD treatment.” This optimism reflects the treatment's promise not only for patients but also its role in advancing precision medicine's application in neurology.
Dr. Werner Poewe, an eminent neurologist and expert on Parkinson’s disease, further highlighted the significance of these results. He remarked on the correlation between clinical improvements and biomarker responses, indicating that ACI-7104.056 may possess the capability to modify disease progression.
Interim Results Overview
The VacSYn trial (ClinicalTrials.gov: NCT06015841) includes 34 early PD patients and is structured into two parts. Participants have completed 12 months of treatment, with some undergoing treatment for up to 18 months. The interim results illustrate that:
- Measured Antibody Response: Antibody titers in serum were over 500-fold higher in the treatment group compared to placebo at week 76.
- Cerebrospinal Fluid (CSF) Analysis: ACI-7104.056 induced a significant increase in antibody levels in CSF, supporting effective drug delivery across the blood-brain barrier.
- Stabilization of Biomarkers: Key biomarkers like a-syn and neurofilament light (NfL) showed stabilization, presenting a promising indication of slowing PD pathology.
Next Steps for ACIU
In light of these findings, AC Immune plans to engage with regulatory authorities to discuss the clinical development plan for ACI-7104.056, aiming to transition towards registration. The final data from the first part of the VacSYn trial is anticipated in mid-2026.
AC Immune will provide an overview of these interim findings during a conference call and webcast today at 9:00 AM ET (15:00 CET).
Conference Call Details
Participants may join the call using the following numbers:
- Switzerland/Europe: +41 (0) 58 310 50 00
- United Kingdom: +44 (0) 207 107 06 13
- United States: +1 (1) 631 570 56 13
For additional details, a live and archived webcast will be accessible on the company's website.
About ACI-7104.056
ACI-7104.056 is an optimized formulation of AC Immune's previously validated anti-alpha-synuclein immunotherapy, aimed at generating a target-specific immune response to combat the underlying pathology of Parkinson’s disease.