Encouraging Initial Outcomes in Parkinson’s Immunotherapy by AC Immune
AC Immune, headquartered in Lausanne, concentrates on the advancement of therapies for neurodegenerative disorders, actively working on several immunotherapies aimed at both Alzheimer’s and Parkinson’s diseases.
The phase 2 VacSYn clinical trial is assessing a vaccine-like immunotherapy (ACI-7104.056) intended to target the accumulation of alpha-synuclein within neurons in the brain, a condition linked to the later stages of Parkinson’s disease.
Today, the company disclosed results from the initial three months of treatment in the first segment of this two-part clinical trial. AC Immune intends to publish additional findings from this first phase in the first half of 2025, alongside a decision regarding a potential progression to the next phase of the trial.
The first segment of the trial included 30 early-stage Parkinson’s patients, who were randomly assigned to receive either ACI-7104.056 or a placebo at a 3:1 ratio. Should AC Immune choose to enter the second phase, they will look to recruit up to 150 more participants and assess the therapy’s effects on both motor and non-motor symptoms.
Data obtained from the initial three months reveal that all patients receiving the immunotherapy exhibited an immune response, with the average response in the treatment group showing anti-alpha-synuclein antibody levels that were 16 times greater than those in the placebo cohort.
Thus far, no significant adverse effects have been reported. The most frequently noted side effects included injection site reactions in 49% of participants and headaches in 18% of the subjects involved in the trial.
“The degree of immunogenicity observed after just three months of treatment, alongside the persistently positive safety profile, underscores the exceptional qualities of our clinically validated anti-alpha-syn active immunotherapy for Parkinson’s disease treatment,” stated Andrea Pfeifer, CEO of AC Immune.
“As a leading company in active immunotherapy for neurodegenerative diseases, with two candidates recognized by the FDA as Fast Track designated, we are excited about these preliminary VacSYn data. They further validate our strategy of employing active immunotherapies to target the key pathological proteins of neurodegenerative diseases before significant damage occurs.”
An Innovative Approach to Neurodegenerative Disease Treatment
Parkinson’s disease, a neurodegenerative ailment, is estimated to impact at least 1% of individuals over the age of 60, with risk factors increasing with age. Known to affect motor functions, the disease is characterized by involuntary tremors and difficulties in movement, while at later stages, cognitive decline may also occur.
Individuals with Parkinson’s progressively gather the protein alpha-synuclein in irregular aggregates within neurons, known as Lewy bodies, which are also found in those with dementia with Lewy bodies.
AC Immune is developing multiple immunotherapies designed to prevent the accumulation of abnormal proteins within the brain for both Parkinson’s and Alzheimer’s diseases, essentially adopting a preventative stance at the initial signs of the disease.
Alongside ACI-7104.056, the company is also advancing two additional immunotherapies targeting Alzheimer’s disease: an anti-amyloid beta and an anti-pTau active immunotherapy. These projects are likewise in phase 2, focusing on halting the buildup of amyloid plaques and tau tangles in Alzheimer’s patients’ brains.