AC Immune SA disclosed that its Phase 2 VacSYn trial of ACI‑7104.056, an active immunotherapy targeting alpha‑synuclein, met all immunogenicity targets and produced favorable biomarker trends in early Parkinson’s disease patients. The 34‑patient, 3:1 randomized study showed stabilization of alpha‑synuclein CSF levels, neurofilament light chain, plasma GFAP, and DaT‑SPECT imaging, suggesting a potential disease‑modifying effect.
The interim analysis, covering patients treated for at least 12 months and up to 18 months, also indicated a trend toward stabilization in Movement Disorder Society‑Unified Parkinson’s Disease Rating Scale Part III scores. No serious adverse events were attributed to the drug; the most common side effects were transient injection‑site reactions (56 %), headaches (15 %), and fatigue (12 %).
AC Immune’s financial position remains a concern, with significant net losses and a high cash burn rate. The positive clinical data, however, could improve the company’s trajectory by attracting new funding or partnerships and positioning it as a leader in alpha‑synuclein‑targeted therapies, a space that has seen recent disappointments.
The announcement was met with a strong market reaction, with analysts upgrading their outlooks on the basis of the disease‑modifying signal, biomarker stabilization, and robust safety profile. The data also reinforced confidence in the company’s active immunotherapy platform, which has been a strategic focus since its restructuring.
Dr. Andrea Pfeifer, CEO of AC Immune, said the results “hold the promise of a tremendous step forward for millions of patients” and that the data “underlines the potential to transform treatment.” Neurologist Werner Poewe added that the trial “provides the first evidence that targeting the underlying pathology of Parkinson’s with active immunotherapy could slow disease progression,” highlighting the broader implications for the field.
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