ACI-24 generated an encouraging immune response that correlated with a signal of target engagement in patients with Down syndrome (DS)
Full Phase 1b results support the continued clinical development of anti-Abeta vaccine approaches in DS-related Alzheimer’s disease (AD)
The presentations highlight precision medicine approaches to enable the early detection and prevention of neurodegenerative diseases by targeting amyloid beta (Abeta) and alpha-synuclein (a-syn). The first virtual oral presentation includes the full results from a first-of-its-kind Phase 1b clinical trial evaluating the anti-Abeta vaccine ACI-24 in adults with DS. Previously announced topline data from the trial showed that ACI-24 generated evidence of immunogenicity along with a positive pharmacodynamic response and a favorable safety and tolerability profile.
The Phase 1b study results showed that ACI-24 was safe and well tolerated in adults with DS. No serious adverse events or evidence of central nervous system (CNS) inflammation, meningoencephalitis, or ARIA (amyloid-related imaging abnormalities), including ARIA-E (edema) and ARIA-H (hemorrhage), were reported. Data also showed that administration of ACI-24 resulted in encouraging immune responses that correlated with increases in plasma Abeta, which are indicative of target engagement.
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “The full data set from our Phase 1b DS study are promising and highlight AC Immune’s expertise in active vaccination approaches for neurodegenerative disease. Based on these results, we plan to advance an optimized formulation of ACI-24 into late-stage clinical testing to treat and prevent the progression of DS-related AD. This formulation has demonstrated enhanced immunogenicity against the two most toxic Abeta species in non-human primates, positioning it to be a potential breakthrough in Abeta vaccination. We look forward to the program’s continued advancement, which we believe will be accelerated by the recent validation of Abeta as a surrogate trial endpoint in AD.”
Prof. Johannes Streffer, CMO of
Prof. Pfeifer continued, “Through the development of companion diagnostics such as ACI-12589 in PD, we are working to better enable the advancement of the neurodegenerative disease treatment paradigm towards earlier treatment and prevention. We expect the continued development of this program, alongside the advancement of our recently acquired industry-leading anti-a-syn vaccine, to solidify our position at the forefront of PD drug development. We are pleased to have the opportunity to discuss ACI-12589 with the scientific community at AAIC ahead of the anticipated readout from its first-in-human study later this quarter.”
Scientific updates at AAIC, July 26–30, 2021
|Title:||ACI-24 in adults with Down syndrome: Results of a Phase 1b, randomized, placebo-controlled study (3 Star Trial)|
|Presenter:||Oral presentation by Dr.
|Title:||[18F]ACI-12589, a novel alpha-synuclein radiotracer as a biomarker in patients with Parkinson’s disease and other synucleinopathies|
|Date:||July 26–30, 2021|
|Presenter:||Poster presentation by Dr.
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