Pharma Focus Asia

AC Immune Initiates Clinical Study of First-in-class Diagnostic for Parkinson’s Disease

Monday, February 08, 2021

AC Immune SA, a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today 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 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 Q3 2021. 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 (MSA) and Lewy body dementia (LBD). In preclinical studies, ACI-12589 demonstrates significantly improved target occupancy and binds to PD patient-derived tissue with improved sensitivity and specificity compared to AC Immune’s prior-generation candidates. These favorable characteristics highlight the significant potential of ACI-12589 to become the world’s first diagnostic tool for assessing brain alpha-synuclein pathology in PD. An effective diagnostic may enable accurate, potentially earlier diagnosis as well as monitoring of disease progression to facilitate longitudinal drug efficacy measurements in patients.
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “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. 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. We are pleased to have the continued support of the MJFF as we enter the clinic with this promising diagnostic candidate, which, together with our novel therapeutic candidates targeting pathological alpha-synuclein, encapsulate our precision medicine approach to neurodegenerative diseases.”

AC Immune’s PET tracers are derived from the Company’s innovative Morphomer technology platform, which accelerates the design, development and synthesis of conformation-specific, CNS- and cell-penetrant small molecules to power successful diagnostic and therapeutic approaches. The Morphomer™ platform has produced multiple small molecules that have been validated in clinical studies, including both therapeutic and diagnostic candidates that selectively target pathological forms of Tau protein. In addition to ACI-12589, AC Immune is advancing Morphomer-derived small molecule aggregation inhibitors that significantly decrease alpha-synuclein aggregate formation in cellular assays with favorable pharmacokinetic properties for further evaluation in vivo.

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