NEW HAVEN, Conn., Sept. 10, 2025 -- XingImaging in partnership with SynuSight Biotech has received funding of $3.84M from The Michael J. Fox Foundation to conduct studies on 18F-FD4, a specific α-synuclein (α-syn)-targeted PET tracer. Based on prior investigator-initiated trials, the SynuSight Biotech developed technology, showed the potential to become the world's first α-syn-targeted PET tracer for Parkinson's disease (PD), multiple system atrophy (MSA), and rapid eye movement sleep behavior disorder (RBD).
XingImaging is a leading neuroimaging and radiopharmaceutical services company serving 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 help drive the project toward clinical translation.
Parkinson's disease, the second most common neurodegenerative disease after Alzheimer's disease, is estimated to affect over 10 million people worldwide. Characterized by the progressive loss of dopamine neurons and the accumulation of pathological α-syn aggregates in the brain, PD leads to debilitating motor symptoms (e.g., tremors, rigidity) and non-motor complications (e.g., cognitive decline, loss of sense of smell).
Current diagnosis relies heavily on clinical symptom assessment, which often delays detection until significant neuronal damage has occurred. Early-stage symptoms, such as subtle movement changes or sleep disturbances, frequently overlap with other conditions, complicating accurate diagnosis. Current clinical imaging tools of PD (e.g., DATScan) provide valuable insights into dopaminergic dysfunction or metabolic changes—but crucially, they lack molecular specificity for biomarkers. This limitation has hindered timely intervention and the development of disease modifying therapies aimed at halting or reversing disease progression.
SynuSight R&D team leveraged structural biology approaches to systematically determine the molecular architectures of α-Syn fibrils and probe the 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-Syn fibrils targeting. Preclinical and early clinical data demonstrate, a robust and selective binding to α-syn fibrils and allows identification of α-syn pathology in the early stage of synucleinopathies, enabling proactive therapeutic strategies.
Roger Gunn, CSO at Xing Imaging, and PI says, "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. We are deeply grateful for the support of the Michael J. Fox Foundation and share their commitment to developing a robust PET imaging biomarker targeting the core pathological hallmark of PD. 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."
Roger Fan, CEO at SynuSight Biotech, says 'We are deeply honored to receive support from the Michael J. Fox Foundation for the development of the 18F-FD4 program. 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. Ultimately, we believe this tracer has the potential to transform the diagnosis and management of diseases and benefit millions of patients worldwide.'
"We continue to monitor the tremendous progress and advances in alpha-synuclein imaging," says Jamie Eberling, PhD, senior vice president of research resources at The Michael J. Fox Foundation. "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."
About SynuSight:
SynuSight Biotech is committed to pioneering transformative diagnostic and therapeutic solutions for neurodegenerative diseases through cutting-edge scientific expertise and innovative technology platforms, ultimately benefiting millions of patients worldwide.
SynuSight team specializes in studying the misfolding and pathological aggregation of proteins such as α-Syn, tau, and Aβ. By integrating cutting-edge technologies like Cryo-EM electron diffraction, Helical filament imaging, and In-cell NMR spectroscopy, SynuSight has built unparalleled expertise in key neurodegenerative disease targets, unlocking new possibilities for innovative therapeutic molecule development.
About XingImaging:
XingImaging is based in New Haven, CT with over 24,000 sq ft. of research space and over 50 staff members. Our team is organized into Clinical, Chemistry, and Imaging Sciences divisions with administrative and project support including Regulatory Affairs, Quality Assurance, Imaging and Data Management Services, Information Technology, and Business Operations.
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