AC Immune has reported additional interim safety and positive immunogenicity outcomes from its placebo-controlled Phase II VacSYn trial of anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056 for early Parkinson’s disease (PD) treatment.
This adaptive and biomarker-based trial comprises two parts, with Part 1 involving the initial analyses of more than 30 subjects who are randomised at a 3:1 ratio to receive either the therapy or placebo.
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AC Immune noted that interim outcomes indicated “positive” antibody responses “induced” against the target antigen at week six following two immunisations, “boosted” by additional immunisations.
In the trial, ACI-7104.056 treatment led to an average increase in anti-a-syn antibodies more than 20-fold higher than the background level of the placebo post four immunisations.
The company might commence Part 2 of the trial involving up to 150 subjects, on the basis of further interim outcomes, which will be expected this year, inclusive of biomarker and pharmacodynamic data.
In this part, the assessment of additional exploratory endpoints for subjects, such as the progression of non-motor and motor symptoms, along with imaging, fluid, and digital biomarkers, will be included.
The goal is the establishment of early proof-of-concept and to identify disease-specific biomarkers for a quick swift into a pivotal trial.
AC Immune CEO Dr Andrea Pfeifer said: “We continue to be encouraged by the data emerging from the Phase II VacSYn trial of ACI-7104.056 active immunotherapy in early PD.
“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 PD.”
AC Immune’s SupraAntigen and Morphomer technology platforms support its pipeline of therapeutic and diagnostic programmes, which also include the Phase II and Phase III development candidates.
The company reported positive initial interim data from the Phase Ib/II ABATE trial of its ACI-24.060 anti-amyloid-beta vaccine for prodromal Alzheimer’s disease, in 2023.
