Clinical Trials

Date: 2017-09-12

Type of information: Completion of patient enrollment

phase: 1b

Announcement: completion of patient enrollment

Company: AC Immune (Switzerland) University of California San Diego (USA - CA)

Product: ACI-24

Action mechanism:

vaccine. ACI-24 is a liposomal therapeutic anti-Abeta vaccine, discovered utilizing AC Immune SupraAntigen™ technology platform. 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 beta amyloid plaque accumulation and to enhance plaque clearance. Preclinical data demonstrate 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 inflammatory T-cells.
Individuals with Down syndrome (DS) have an extra copy of chromosome 21 which carries the gene for APP encoding the precursor protein of Abeta, one of the hallmarks of Alzheimer’s disease (AD). An important consequence is that individuals with DS develop AD-like characteristics at a rate three to five times greater than that of the general population and at a much younger age. Further, AD-like characteristics develop in more than 98% of people with DS over age 40 with up to 80% developing associated dementia over the age of 60.

Disease: Down syndrome

Therapeutic area: Genetic diseases

Country: USA

Trial details:

The 3 Star study is evaluating the safety, tolerability and immunogenicity of AC Immune’s anti-Abeta vaccine ACI-24 and targeting Abeta related decline in individuals with Down syndrome. It is being conducted in collaboration with the Down Syndrome Center for Research and Treatment at the University of California San Diego (UCSD), St. Joseph’s Hospital and Medical Center and Barrow Neurological Clinics, Phoenix, and Massachusetts General Hospital, Boston, AC Immune and the Alzheimer ’s Disease Cooperative Study at UCSD coordinate the trial. The low dose cohort trial participants are aged 25 to 45 and will be treated for 12 months, with a 12-month safety follow up. The study includes up to 24 participants across all cohorts. Interim results of the first low dose cohort are expected in 2018. The study is being funded through a grant from the US National Institute on Ageing, a part of the US National Institutes of Health (NIH) with an additional grant from the LuMind Research Down Syndrome Foundation. This is the first public/private collaboration for a clinical trial in the field of Down syndrome.(NCT02738450)

Latest news:

• On September 12, 2017, AC Immune announced that it has completed recruitment in its Phase 1b study of the first, low-dose cohort of adults with Down syndrome (DS). In addition to cognitive dysfunction beginning in childhood, individuals with DS are predisposed to develop Alzheimer’s disease-like characteristics at a much younger age and at much higher probability than the general population.
• On January 7, 2016, AC Immune announced plans to conduct the world’s first clinical trial for ACI-24, its vaccine targeting Alzheimer’s disease-like characteristics in those with Down syndrome. The study will test AC Immune’s vaccine ACI-24 and is being conducted in collaboration with the University of California, San Diego (UC San Diego) Down Syndrome Research and Treatment Center. Funding is provided by a significant grant from the US National Institutes of Health (NIH) and an additional grant from the LuMind Research Down Syndrome Foundation. This is the first public/private collaboration for a clinical trial in the field of Down syndrome.
Trial participants will be adults with Down Syndrome. The objectives of the trial include studying safety and tolerability of ACI-24, its effect on induction of antibodies against Abeta, clinical and cognitive measures in adults with DS and its effect on biomarkers of AD-like pathology in Down Syndrome. Participants in the study will be treated for 12 months, with 12 months follow up.