A first-in-class diagnostic for Parkinson’s disease

LAUSANNE, Switzerland—AC Immune SA, a clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, recently announced that the first patient has been scanned in a first-in-human study of its novel diagnostic agent for Parkinson’s disease (PD). 

ACI-12589 is a next-generation positron emission tomography (PET) imaging tracer that has reportedly shown significant potential to reliably detect and map deposits of pathological alpha-synuclein protein in the brain, which is the major hallmark of PD. AC Immune expects to report the results of the study in the third quarter of this year. The clinical study is supported by the Michael J. Fox Foundation for Parkinson’s Research (MJFF), building on the foundation’s significant funding of AC Immune’s program since 2015.

Alpha-synuclein misfolding and aggregation are the molecular basis for the formation of pathological Lewy bodies and neurites, which are characteristic of PD and other alpha-synucleinopathies such as multiple system atrophy and Lewy body dementia. In preclinical studies, ACI-12589 demonstrated significantly improved target occupancy and bound to PD patient-derived tissue with improved sensitivity and specificity compared to AC Immune’s prior-generation candidates.

“The unmet need for reliable, non-invasive diagnostic tools to enable precision medicine approaches in Parkinson’s disease is substantial, which is why our alpha-synuclein PET tracer program is so critical for the field,” said Prof. Andrea Pfeifer, CEO of AC Immune SA. “While inclusions containing misfolded aggregates of this key protein have long been considered an important neuropathology in this debilitating neurodegenerative disease, the means to accurately detect and quantify pathological alpha-synuclein in the brain has remained elusive. 

“With our next-generation PET tracer candidate, we believe there is potential to change this paradigm. ACI-12589 demonstrates ideal properties in preclinical studies using patient-derived brain tissue, which is another testament to the strength of our Morphomer platform and the medicinal chemistry expertise at AC Immune.”

AC Immune’s PET tracers are derived from the company’s Morphomer technology platform, which accelerates the design, development, and synthesis of conformation-specific, central nervous system-penetrant, and cell-penetrant small molecules to power diagnostic and therapeutic approaches.