AC Immune CEO Prof Andrea Pfeifer said: “We are delighted with the progress of ACI-24, the anti-Abeta vaccine, derived from our proprietary SupraAntigenTM platform. In addition to the development in Alzheimer’s Disease, it is currently the only clinical-stage vaccine targeting the associated Abeta-induced cognitive decline in people with Down Syndrome.
“Vaccines are potentially an important option for the treatment and prevention of neurodegenerative diseases and are a key asset in our pipeline.”
AC Immune has started the phase 2 study with ACI-24 in patients with mild Alzheimer’s disease (AD). The aim of this double-blind, randomized, placebo-controlled study with an adaptive design is to assess the safety, tolerability, immunogenicity, target engagement, biomarkers and clinical efficacy of ACI-24.
The trial will seek to confirm the positive trends on Abeta PET* imaging and clinical measurement (CDR-SB°) of the previous Phase 1 safety study. The Phase 2 trial will be conducted in several European countries and the first patients have been screened.
AC Immune has completed recruitment for the high-dose cohort of the ACI-24 Phase°1b study for the treatment of Alzheimer’s disease-like characteristics in adults with Down Syndrome (DS), a condition affecting approximately one in 700 newborns.
The first low-dose and the second high-dose cohorts have been fully recruited in August 2017 and in July 2018 respectively, and interim results of the low dose cohort are expected later in 2018. In addition to cognitive dysfunction beginning in childhood, individuals with DS are genetically-predisposed to develop Abeta-related cognitive decline at a much younger age and with much greater probability than the general population.
ACI-24 is a liposomal therapeutic anti-Abeta vaccine candidate, which generates antibodies specific to disease-causing conformations. The vaccine is designed to stimulate a patient’s immune system to produce antibodies that specifically target the oligomeric and fibrillary Abeta proteins to prevent plaque accumulation and to enhance plaque clearance.
Preclinical data demonstrated a significant activity in plaque reduction and memory restoration as well as a favorable safety profile characterized by a lack of local inflammation and a mode of action independent of T-cells.
The vaccine is being studied in a Phase 2 clinical trial in patients with mild to moderate AD and in a Phase 1b study in young adult DS subjects, and has been proven to be safe with preliminary trends of efficacy.
Source: Company Press Release