Following the release of positive preliminary findings from its Phase 2 VacSYn clinical study, shares of AC Immune SA (NASDAQ: ACIU) saw a notable increase, jumping 13.42% on the charts. The anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056, which targets early-stage Parkinson’s disease (PD), is being evaluated in this experiment. ACIU stock ended Thursday’s trading session at $3.55 after the news.
AC Immune Shares Promising Interim Data
The interim results from the VacSYn trial provided positive data on the safety and immunogenicity of ACI-7104.056. These findings, which were gathered after just three months of treatment, demonstrate the promising immunogenicity levels and continued favorable safety profile.
These findings establish ACI-7104.056 as a top choice for patients with early-stage Parkinson’s disease and confirm its potential as a best-in-class treatment candidate. In the first half of 2025, AC Immune intends to provide more information, which might include a decision to move forward with the trial’s second phase.
VacSYn Study Design and Results
VacSYn is an adaptive, placebo-controlled, biomarker-driven Phase 2 study targeting early Parkinson’s disease. The trial includes two phases, with Part 1 having already completed an analysis of over 30 patients, who were randomized to receive either ACI-7104.056 or a placebo.
Notably, no significant safety concerns were identified, aside from mild side effects like injection site reactions (49%) and headaches (18%). The interim data indicated that ACI-7104.056 was effective in inducing a robust antibody response, with anti-a-syn antibodies reaching levels 16 times higher than the placebo after three immunizations.
Future Plans and Expansion of the Study
Looking ahead, AC Immune may expand Part 2 of the VacSYn trial, potentially involving up to 150 patients. This phase will explore additional outcomes, including the progression of motor and non-motor symptoms, as well as the use of digital, imaging, and fluid biomarkers. These efforts aim to establish early proof-of-concept and identify key biomarkers, supporting a swift transition into a pivotal study.