AC Immune Hosts KOL Event and Reports Initial Interim Clinical Data for ACI-24 Vaccine to Treat Alzheimer’s Disease-like Symptoms in Subjects with Down Syndrome
Anti-Abeta vaccine demonstrates strong safety and preliminary immunogenicity results in subjects with Down syndrome
Presentations underscore significant need and opportunity for studying Alzheimer’s disease-like symptoms in this high-risk and genetically homogeneous population
LAUSANNE,
Professor
The event, which will be recorded and can be viewed here, is being co-chaired by Professor Pfeifer and Professor
Highlights from Dr. Kosco-Vilbois’ presentation include:
- The trial is a fully enrolled, placebo-controlled, 16 subjects Phase 1b study of AC Immune’s ACI-24 anti-Abeta vaccine
- To date, ACI-24 was well tolerated by DS subjects, demonstrating a favorable safety profile at all doses tested, mirroring previous clinical trial results
- There were no subjects withdrawals from the study or serious adverse events (SAE) reported, no signals of CNS inflammation or other pro-inflammatory reactions, no amyloid-related imaging abnormalities (ARIA-E/ARIA-H) or indication of meningoencephalitis
- Preliminary immunogenicity data showed an anti-Abeta IgG response that was detectable at week 4
- Pending the final outcome, the Phase 2 study of ACI-24 in subjects with DS would likely focus on disease prevention and will include biomarkers and Positron Emission Tomography (PET) imaging to monitor disease progression, in addition to quantifying anti-Abeta IgG titers generated by the vaccine.
Dr. Kosco-Vilbois, CSO of
Highlights of Dr. Skotko’s presentation include:
- DS is caused by having a third copy (trisomy) of chromosome 21 and occurs in 1/~792 live births; ~5,000 children per year
- ~212,000 people living with DS in the US and ~359,000 in
Europe - Adults with DS are increasingly moving into semi-independent living situations and securing paid employment, are involved in romantic relationships and marry, participate in day habilitation services or are active participants in sports (
Special Olympics ) - Initial symptoms are typically changes in behavior; seizures can also be an early warning sign, followed by memory loss
- Based on surveys, family members and people with DS say they are satisfied, even positive, about their lives despite acknowledging the challenges that accompany DS
Highlights from Professor Mobley’s presentation include:
- The neuropathological changes in DS subjects are very similar but not identical to typical AD. People with Down syndrome have an extra copy of chromosome 21, which houses the gene that codes for amyloid precursor protein (APP). APP is the parent protein of Abeta, a protein fragment that accumulates into amyloid plaques, a key feature of AD
- Studying AD-like symptoms in the DS population addresses many of the key dilemmas that hinder the discovery of new treatments: uncertain mechanisms and timing of disease-induced brain changes, difficulty offering treatment before disease onset, genetic and age-related variability, and the risk of including subjects with other forms of age-related dementia
- For AD in DS, the disease mechanism and approximate timing of onset are known; readily detectable pathological changes occur prior to AD-like symptoms, enabling treatment prior to disease onset; the DS population is far more homogeneous and carries minimal risk of having coexisting conditions causing dementia at such a young age
- In mouse models of DS, vaccination against Abeta by ACI-24 improved cognition and prevented neuronal atrophy
Professor Mobley commented: “DS is an underrepresented, overlooked population at increased risk for AD-like disease. It offers opportunities for exploring effective treatments for AD that will benefit both the DS and general populations. Homogeneity in pathogenesis, age-related disease onset and absence of other dementias powerfully enable prevention trials of AD-like symptoms in DS. I am encouraged by the body of evidence supporting this rationale and personally gratified to be conducting the first clinical trial of a vaccine against Abeta in individuals with DS.”
DS is characterized by the onset of AD-like symptoms by age 20, and nearly all DS subjects display AD-like symptoms by age 40. Treating AD-like symptoms in DS subjects is imperative and information from this patient population may also be pivotal for developing successful treatments for the broader AD population. Many KOLs – and
Key Opinion Leader Biographies:
Professor
Dr. Brian Skotko, M.D., M.P.P., is a Board-certified medical geneticist and the Emma Campbell Endowed Chair on Down Syndrome at Massachusetts General Hospital. As the Director of the hospital’s Down Syndrome Program, he has dedicated his professional energies toward children with cognitive and development disabilities. Dr. Skotko co-authored the national award-winning books, Common Threads: Celebrating Life with Down Syndrome and Fasten Your Seatbelt: A Crash Course on Down Syndrome for Brothers and Sisters. He is a graduate of Duke University, Harvard Medical School, and Harvard Kennedy School, and he is currently an Associate Professor at Harvard Medical School. Dr. Skotko is a leader on clinical and translational research in the field of Down syndrome. He has been featured in
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US Investors Joshua Drumm, Ph.D. AC Immune Investor Relations Phone: +1 646 876 5538 E-mail: joshua.drumm@acimmune.com |
US Media Katie Gallagher or Sharon Correia LaVoieHealthScience Phone: +1 617 792 3937 E-mail: kgallagher@lavoiehealthscience.com scorreia@lavoiehealthscience.co |
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