AC Immune (NASDAQ: ACIU) announced positive results from Part 1 of its VacSYn Phase II trial for ACI-7104.056, an active immunotherapy targeting aggregated alpha-synuclein in early Parkinson’s disease. The placebo-controlled trial, involving 34 participants (25 received the treatment, 9 received placebo), lasted 18 months with a subsequent six-month safety follow-up.
The study met primary safety, tolerability, and immunogenicity goals, with all treated participants developing detectable antibody responses after three vaccinations. Participating patients, aged 62 on average, reported injection-site reactions, headaches, and fatigue as common side effects. The Data Safety Monitoring Board recommended continuing the trial without modifications. AC Immune plans to expand the trial with an additional cohort and discuss future phases with the FDA.
Preliminary findings showed stabilization of CSF total alpha-synuclein levels in the treated group and trends indicating better outcomes in anti-alpha-synuclein antibody levels correlated with improved motor scores. Follow-up for Part 1 participants will occur over four years, and a planned Part 2 will involve around 250 patients over 24 months for further assessments.
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