XingImaging and SynuSight Biotech have secured $3.84 million in funding from The Michael J. Fox Foundation to advance development of 18F-FD4, a groundbreaking α-synuclein-targeted PET tracer that could become the world's first molecular imaging tool specifically designed for Parkinson's disease diagnosis. The grant will support clinical studies aimed at validating this novel diagnostic approach for Parkinson's disease, multiple system atrophy, and rapid eye movement sleep behavior disorder.
Addressing Critical Diagnostic Gaps
Parkinson's disease affects over 10 million people worldwide as the second most common neurodegenerative disease after Alzheimer's. The condition is characterized by progressive loss of dopamine neurons and accumulation of pathological α-synuclein aggregates in the brain, leading to debilitating motor symptoms including tremors and rigidity, as well as non-motor complications such as cognitive decline and loss of smell.
Current diagnostic approaches rely heavily on clinical symptom assessment, which often delays detection until significant neuronal damage has occurred. Early-stage symptoms frequently overlap with other conditions, complicating accurate diagnosis. While existing clinical imaging tools like DATScan provide insights into dopaminergic dysfunction, they crucially lack molecular specificity for biomarkers, hindering timely intervention and development of disease-modifying therapies.
Innovative Structural Biology Approach
SynuSight's research team leveraged structural biology approaches to systematically determine the molecular architectures of α-synuclein fibrils and probe binding specificity between candidate molecules and this pathological biomarker. These insights enabled the rational design of FD4, a novel PET tracer engineered for selective α-synuclein fibrils targeting.
Preclinical and early clinical data demonstrate robust and selective binding to α-synuclein fibrils, allowing identification of α-synuclein pathology in the early stages of synucleinopathies and enabling proactive therapeutic strategies.
Partnership and Clinical Translation
XingImaging, a leading neuroimaging and radiopharmaceutical services company, serves as SynuSight's preclinical and clinical CRO partner. Under the grant framework, XingImaging will provide critical support for regulatory filings and clinical trial execution while delivering key scientific expertise to drive the project toward clinical translation.
"This represents a pivotal opportunity to advance one of the most promising alpha-synuclein PET tracers in humans, ensuring its full characterization and optimization for imaging in Parkinson's disease," said Roger Gunn, CSO at XingImaging and principal investigator. "Such a biomarker would significantly enhance our understanding of the disease, its progression, and will play a central role in clinical trials evaluating new treatments."
Early Clinical Success
Roger Fan, CEO at SynuSight Biotech, highlighted the promising early results: "Our early Investigator-Initiated Trials have already demonstrated superior imaging performance in patients with PD, MSA, and RBD. Backed by the MJFF grant, we are now well-positioned to accelerate our validation efforts through additional clinical studies with XingImaging and fully unleash the potential of 18F-FD4 to advance the development of disease-modifying therapies."
Jamie Eberling, PhD, senior vice president of research resources at The Michael J. Fox Foundation, emphasized the significance of this development: "XingImaging and SynuSight Biotech's F-FD4 programming is another hopeful step toward an urgently needed tool that could clearly measure, quantify and visualize brain pathology in Parkinson's disease."
Advanced Technology Platform
SynuSight Biotech specializes in studying the misfolding and pathological aggregation of proteins such as α-synuclein, tau, and amyloid-β. The company integrates cutting-edge technologies including Cryo-EM electron diffraction, helical filament imaging, and in-cell NMR spectroscopy to build expertise in key neurodegenerative disease targets, unlocking new possibilities for innovative therapeutic molecule development.
The successful development of 18F-FD4 could transform the diagnosis and management of neurodegenerative diseases, potentially benefiting millions of patients worldwide by enabling earlier detection and more targeted therapeutic interventions.
