– Sunbird’s diagnostic technology classified Parkinson’s disease-positive blood samples with 86% accuracy through the direct detection of aggregated alpha synuclein proteins –

– Aggregation of alpha synuclein in the brain is a hallmark of Parkinson’s disease, which currently has no approved blood-based diagnostic tests –

– Results shared at the 17^th annual Clinical Trials on Alzheimer’s Disease (CTAD) international conference –

Sunbird Bio, a biotechnology company developing proprietary blood-based technologies to improve diagnosis and treatment of neurological disorders and early-stage cancer, announced new data demonstrating that the company’s blood-biomarker alpha synuclein (α-synuclein) signatures accurately detect the aggregation of α-synuclein in the brain from a simple blood draw. Results from the study, which will be shared in a poster presentation (#116) on October 31 at the Clinical Trials on Alzheimer’s Disease (CTAD) international conference, demonstrate that Sunbird’s technology could provide blood-based diagnosis of multiple neurodegenerative diseases, including Parkinson’s disease, with high accuracy.

The aggregation of α-synuclein proteins in the brain is a hallmark of several neurodegenerative diseases – most notably Parkinson’s disease, dementia with Lewy bodies and multiple system atrophy. Currently, there are no specific blood-based diagnostic tests available for Parkinson’s disease, and a diagnosis is typically made based on symptoms, medical history and a detailed physical examination. The Sunbird Bio study being shared at CTAD 2024 evaluated the potential of extracellular vesicle (EV)-bound α-synuclein proteins in the blood to serve as an effective method for directly detecting α-synuclein aggregation in the brain, thus indicating the presence of Parkinson’s disease.

“We’re excited to share the first data from a clinical trial of our proprietary alpha synuclein biomarker signatures, which validate the potential of our blood-based platform to provide the first clinical diagnostic test for Parkinson’s disease,” said John McDonough, executive chairman and CEO of Sunbird Bio. “These data also reinforce our technology’s ability to accurately and directly detect a number of aggregated proteins from the brain that are key to the diagnosis of a range of neurological disorders – all with a single blood draw. We are diligently advancing our diagnostic platform to address the tremendous, growing need for more sensitive, reliable and non-invasive diagnostic tests to improve outcomes in these disorders.”

Researchers in the Sunbird study prospectively collected blood samples from 16 individuals who were Parkinson’s disease-positive, as well as from 24 age-matched healthy individuals. They then evaluated the ability of Sunbird Bio’s proprietary α-synuclein assays to accurately distinguish between EV-bound and unbound soluble forms of α-synuclein in plasma.

Results suggest that a Sunbird-designed blood biomarker “control” signature composed of unbound soluble α-synuclein was unable to classify Parkinson’s disease-positive samples, while the Sunbird Bio signature composed of brain-derived EV-bound α-synuclein accurately classified Parkinson’s disease-positive samples with an area under the curve (AUC) of 0.86, indicating high accuracy in disease detection. These findings are not only applicable to the detection of Parkinson’s disease, but also could have important implications in other neurological disorders, including Alzheimer’s disease, that have common co-pathologies associated with α-synuclein aggregation.

A-synuclein proteins play a critical role in synaptic function, and when they form insoluble fibrils and Lewy body aggregates in the brain, it can disrupt cellular function, impair synaptic transmission and activate neuroinflammatory pathways which can lead to neuronal death. When aggregated α-synuclein proteins bind to nanoscale EVs in the brain, they are able to pass through the blood-brain barrier into the bloodstream. While detecting aggregated α-synuclein proteins with accuracy is challenging for most blood tests, Sunbird Bio’s proprietary diagnostic approach has proven the ability to do so across multiple biomarkers.

“Research has only recently uncovered the pivotal role that alpha synuclein proteins play in the pathogenesis of Parkinson’s disease and Alzheimer’s disease, and the ability to accurately detect the aggregation of these proteins from a blood test could transform how these diseases are diagnosed,” said Huilin Shao, Ph.D., founder of Sunbird Bio. “These data support the initiation of additional clinical trials incorporating more biomarkers and a broader array of blood samples to further evaluate our technology’s potential to accurately diagnose Parkinson’s disease and other synuclein-related neurological disorders. We recognize the critical need for improved diagnostic technologies and are working with urgency to deliver them to physicians and patients.”

Sunbird Bio’s first-of-its-kind diagnostic technology directly detects and measures very low concentrations of EV-bound, aggregated proteins in blood. Data to date demonstrate its potential to offer an accurate and accessible diagnostic that not only aids in disease detection, but also drug development, disease monitoring and personalized treatment selection for Parkinson’s disease, Alzheimer’s disease and other neurological disorders. The company has an active pipeline that includes blood-based tests for amyloid beta, tau, α-synuclein, TDP-43 and other biomarkers for neurological diseases.

About Sunbird Bio

Sunbird Bio is a biotechnology company developing proprietary blood-based diagnostic tests that provide unprecedented insights to enable earlier, more accurate diagnosis and treatment of neurological disorders and early-stage cancer. Sunbird’s innovative technologies uniquely detect the property and activity of proteins to empower researchers and clinicians with actionable information that is not available or accessible from current tests. Sunbird Bio’s unparalleled leadership in blood-based diagnostics positions the company to become a global leader in the field, addressing significant research and clinical gaps, and serving multiple, sizable markets. For more information, please visit sunbirdbio.com.

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