AC Immune's ACI-7104.056 Demonstrates No Safety Concerns in Early Trials

AC Immune SA's clinical-stage biopharmaceutical company has reported that its ACI-7104.056 product is well tolerated with no safety issues to date. The Switzerland-based company focuses on precision medicine for neurodegenerative diseases, including Alzheimer's disease. Its pipeline includes nine therapeutic product candidates, with five in clinical trials, and three diagnostic candidates. AC Immune SA has collaborations with pharmaceutical companies such as Roche/Genentech, Eli Lilly, and Biogen.

AC Immune SA, a Switzerland-based clinical-stage biopharmaceutical company, has announced additional positive interim results from its Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of early Parkinson’s disease (PD). The trial has demonstrated that the product induces high anti-a-syn antibody levels on average over 20-fold higher than placebo after four immunizations, underscoring its potential for effective treatment.

The study, an adaptive, placebo-controlled, and biomarker-based Phase 2 trial, consists of two parts with a seamless transition. Part 1 includes initial analyses from over 30 patients randomized to receive ACI-7104.056 or placebo at a ratio of 3:1. The most common adverse events are mild and transient, with no serious adverse events considered related to the study drug reported to date.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented, “We continue to be encouraged by the data emerging from the Phase 2 VacSYn trial of ACI-7104.056 active immunotherapy in early Parkinson’s disease. These additional interim safety and immunogenicity data after six months of treatment underscore the good safety profile and reinforce the best-in-class characteristics of ACI-7104.056 for the treatment of Parkinson’s disease. We look forward to sharing further updates later in 2025.”

AC Immune SA focuses on precision medicine for neurodegenerative diseases, including Alzheimer's disease. Its pipeline includes nine therapeutic product candidates, with five in clinical trials, and three diagnostic candidates. The company has collaborations with major pharmaceutical companies such as Roche/Genentech, Eli Lilly, and Biogen.

The company's lead product candidate, Crenezumab, is a humanized and monoclonal anti-Abeta antibody for Alzheimer’s disease. AC Immune's SupraAntigen and Morphomer technology platforms enable the creation of antibodies, small molecules, and vaccines designed to address a broad range of neurodegenerative indications.

These latest results from the VacSYn trial further support AC Immune's approach to using active immunotherapies to target the hallmark pathological proteins of neurodegenerative diseases, such as a-synuclein in Parkinson’s disease, before irreversible damage occurs.