AC Immune reports Phase 2 Parkinson’s results

• AC Immune (NASDAQ:ACIU) reported that all primary endpoints were met at week 100 in Part 1 of its Phase 2 VacSYn trial of ACI-7104.
• The trial showed a 100% antibody response rate after three immunizations, with ACI-7104 generally safe and well tolerated.
• AC Immune is continuing the two-year extension study and preparing the Part 2 expansion design for FDA review.

AC Immune (NASDAQ:ACIU) reported that all primary endpoints were met at week 100 in Part 1 of its Phase 2 VacSYn trial evaluating ACI-7104 in early Parkinson’s disease.

The randomized, double-blind, placebo-controlled study included 34 patients, with 25 receiving ACI-7104 and nine receiving placebo, and showed the treatment was generally safe and well tolerated.

ACI-7104 produced a 100% antibody response rate after three immunizations against the PD01 α-synuclein target antigen, with antibody reactivity against aggregated α-syn species observed in treated patients.

Exploratory analyses showed a signal in total α-synuclein levels in cerebrospinal fluid, which the company said was consistent with target engagement, along with trends connecting antibody levels with disease activity measures.

AC Immune said Part 1 of the VacSYn trial continues through its two-year extension, while the Part 2 expansion design is being finalized for FDA review with discussions expected in early 2027.