Therapy shows high efficacy in initial trial phase
AC Immune SA has reported encouraging interim results from its phase 2 VacSYn clinical trial of ACI-7104.056, an anti-alpha-synuclein (a-syn) active immunotherapy for early Parkinson’s disease (PD).
The trial, involving over 30 patients, showed that ACI-7104.056 induced high levels of anti-a-synuclein antibodies, averaging 16-fold higher than those in the placebo group after three immunizations.
Dr Andrea Pfeifer, CEO of AC Immune, remarked, “We are encouraged by these initial Phase 2 safety and immunogenicity data on our ACI-7104.056 active immunotherapy being studied in early Parkinson’s disease.
The level of immunogenicity after only 3 months of treatment as well as the continued positive safety profile, reinforces the best-in-class characteristics of our clinically validated anti-a-syn active immunotherapy for the treatment of Parkinson’s disease.”
The trial, which is randomized, placebo-controlled, and biomarker-based, is being conducted across various countries, including the UK and Spain. It aims to recruit up to 30 patients with mild-to-moderate PD.
The interim results have shown that 100% of patients receiving ACI-7104.056 responded positively against the target antigen, with no significant safety issues reported other than transient injection site reactions and headaches.
Dr Pfeifer further stated, “As a leader in active immunotherapies for neurodegenerative diseases with two FDA Fast Track designated candidates, an important recognition of their promise, we are delighted with these initial VacSYn data.”
She added: “They further support the approach of using active immunotherapies to target the hallmark pathological proteins of neurodegenerative diseases, such as a-synuclein in Parkinson’s disease, before irreversible damage occurs.”
The next phase of the trial, expected to start in 2025, will involve up to 150 patients and will evaluate the progression of motor and non-motor symptoms, as well as digital, imaging, and fluid biomarkers.
The aim is to establish early proof-of-concept and identify disease-specific biomarkers for rapid transition into a pivotal study.
This was shown first on: https://pharmatimes.com/news/ac-immune-announces-positive-trial-results-for-early-parkinsons-treatment/
