Enigma Biomedical USA Awarded $2 Million Grant from The Michael J. Fox Foundation to Advance Novel α-Synuclein PET Imaging Biomarker for Parkinson’s Disease
Enigma Biomedical USA (EB USA) today announced that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has awarded the company a grant of $2 million to support the discovery and early preclinical development of a groundbreaking α-synuclein Positron Emission Tomography (PET) imaging biomarker. The project represents a major step toward creating the first reliable imaging tool capable of detecting one of the core biological features of Parkinson’s disease (PD) in living patients.
The newly awarded funding aligns with MJFF’s long-standing mission to accelerate research that can transform the understanding, diagnosis, and treatment of Parkinson’s disease. As part of its strategic scientific agenda, the Foundation continues to prioritize the development of objective, biological measurement tools — also known as biomarkers — which can help quantify disease progression, improve clinical trial design, and evaluate the effectiveness of emerging therapies.
Addressing a Critical Unmet Need in Parkinson’s Disease Biology
Parkinson’s disease remains one of the most challenging neurodegenerative disorders to diagnose and track because its symptoms evolve gradually and vary significantly from person to person. At a biological level, PD is marked by the misfolding and accumulation of a protein called α-synuclein, which aggregates into clumps or Lewy bodies in the brain. These Enigma pathological protein accumulations are strongly linked to progressive neuronal dysfunction and ultimately give rise to both motor and non-motor symptoms of the disease.
Despite α-synuclein’s fundamental role in PD pathology, there is currently no clinically validated imaging modality capable of detecting or quantifying α-synuclein in the living brain. Physicians today rely on a patient’s symptoms, medical history, and clinical examinations to diagnose Parkinson’s — a process that is subjective, variable, and often delayed until substantial neuronal damage has already occurred.
A validated α-synuclein PET imaging agent could change that landscape profoundly. Such a biomarker would allow clinicians and researchers to visualize the protein directly in the brain, enabling earlier and more accurate diagnosis and supporting development of targeted therapies aimed at slowing or halting disease progression.
A New Framework for Disease Understanding and Classification
Recent advances in research have shifted the global understanding of Parkinson’s disease. Rather than viewing PD as a condition defined solely by observable symptoms, scientists now recognize it as part of a biological continuum involving α-synuclein pathology. Under this evolving paradigm, diseases like Parkinson’s disease and dementia with Lewy bodies (DLB) are increasingly categorized based on underlying biological features instead of clinical presentation alone.
A new standardized staging framework for PD and related synucleinopathies reflects this approach. It suggests that Parkinson’s exists along a spectrum: from early biological changes that create disease risk, through defined biomarker-positive stages, and eventually to symptomatic impairment. A reliable tool for detecting α-synuclein in the Enigma brain would accelerate this shift from symptom-based diagnosis to precision medicine, where biology drives care decisions.
Science and Innovation: Building on Transformational Chemistry and Imaging Expertise
The discovery research supported by the new MJFF grant will leverage award-winning scientific innovation. The Enigma program is rooted in the Nobel Prize-winning Click Chemistry framework, which enables highly efficient, targeted chemical reactions ideally suited for PET tracer design.
This project will be led by Hartmuth Kolb, Ph.D., Chief Science Officer at EB USA, whose contributions to biomarker science have been widely recognized across the neuroscience field. Dr. Kolb will conduct the work in collaboration with the University of Wisconsin, where he serves as a Visiting Professor.
Dr. Kolb brings a remarkable scientific track record to the effort. Earlier in his career, he led the research team responsible for developing the world’s first clinically deployed Tau PET imaging biomarker, a breakthrough that dramatically advanced Alzheimer’s disease research, diagnosis, and drug development. His role as a pioneer in neurodegenerative biomarker discovery strengthens the likelihood that this research initiative could achieve similar transformational impact for Parkinson’s disease and related synucleinopathies.
Urgency Driven by the Growing Burden of Parkinson’s Disease
Parkinson’s disease is the fastest-growing neurodegenerative disease globally. More than 10 million people worldwide currently live with PD, and incidence rates continue to rise. PD is characterized primarily by the loss of dopaminergic neurons, which progressively impairs movement control. Yet the disease also causes cognitive, emotional, sensory, and autonomic symptoms, many of which appear long before motor signs.
The need for therapies that modify disease progression rather than merely treat symptoms has never been greater. A PET tracer capable of measuring α-synuclein — the key pathological protein driving disease — could be the single most impactful tool for accelerating treatment development. As demonstrated in Alzheimer’s research, once imaging biomarkers became available, the field rapidly advanced. Today, multiple disease-modifying Alzheimer’s treatments exist because researchers were finally able to track pathology directly and objectively.
A similar breakthrough in Parkinson’s disease could profoundly reshape research, diagnosis, and care.
Leadership Statements Reflect Shared Commitment
Dr. Hartmuth Kolb expressed appreciation for the Foundation’s investment and optimism about the road ahead:
We are extremely grateful to The Michael J. Fox Foundation for this recognition and generous support. We are excited to begin this work, and we hope it will have a significant impact on improving understanding and management of this devastating disease.”
Rick Hiatt, President and CEO of Enigma Biomedical USA, emphasized the alignment between the mission of EB USA and MJFF:
“EB USA is very pleased with our expanding partnership with The Michael J. Fox Foundation. Both organizations are committed to addressing critical unmet needs in neurodegenerative disease and to building tools that can accelerate disease-targeted therapy development.”
Representing MJFF, Sohini Chowdhury, Chief Program Officer, highlighted the momentum building across the research community:
We are encouraged by the collective progress in advancing the Enigma diagnostic and therapeutic tools urgently needed to speed Parkinson’s drug development. We look forward to continued efforts from the Enigma Biomedical team in developing an imaging tracer for alpha-synuclein pathology. This effort has the potential to strengthen clinical research design, improve diagnosis, and help drive the development of better treatments that patients and families deserve.”
A Step Toward Earlier Diagnosis and Precision Medicine
The development of a reliable α-synuclein PET biomarker holds enormous potential for transforming the trajectory of Parkinson’s disease. From accelerating Enigma clinical trials to enabling personalized therapeutic strategies, the implications are far-reaching. With support from The Michael J. Fox Foundation, Enigma Biomedical USA is now positioned to pursue a scientific milestone that could redefine how Parkinson’s disease is understood and treated worldwide.
About Enigma Biomedical – USA
Enigma Biomedical USA’s vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology, and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. EB’s neuroimaging biomarkers provide Pharma and Academic researchers with state-of-the-art tools for enabling Disease-Modifying Therapy development with the highest precision and accuracy. In Enigma pursuit of this vision, subsidiaries of EB have provided the best-in-class Tau and Amyloid PET imaging biomarkers, MK-6240 and NAV-4694, to our partners to enable their research efforts. EB also recently announced a partnership with AbbVie to explore their novel 4R Tau PET Imaging Biomarkers.
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