CND Life Sciences Receives Grant from The Michael J. Fox Foundation to Study Quantification of Cutaneous Phosphorylated Alpha-Synuclein (P-SYN) in People with Parkinson's Disease

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Nov 20, 2024, 08:04 ET

Grant funding will support the new Syn-Q Clinical Study to further investigate the quantification of P-SYN in skin biopsies using CND's Syn-One Test^®

SCOTTSDALE, Ariz., Nov. 20, 2024 /PRNewswire/ -- CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced that it has been awarded a $4.2M grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF). The award will support an 18-month clinical initiative, the Syn-Q Study, to investigate the use of the Syn-One Test^® to quantify abnormal phosphorylated alpha-synuclein in patients with Parkinson's disease over time. Syn-One is a skin biopsy assay that detects and visualizes phosphorylated alpha-synuclein in cutaneous nerves, a key indicator of Parkinson's disease and other related disorders known as synucleinopathies.

"This grant from MJFF will accelerate our efforts to quantify and monitor alpha-synuclein progression over time," said Todd Levine, MD, Chief Medical Officer, CND Life Sciences. "We are optimistic that these efforts will aid in the advancement of the field for those living with Parkinson's disease and other synucleinopathies."

"Biomarkers are critical to early diagnosis and the development of effective treatments for Parkinson's disease," said Mark Frasier, PhD, Chief Scientist, MJFF. "The Foundation supports an aggressive agenda to develop quantitative biomarkers of progression that enables research and improves clinical trials. We look forward to seeing the outcomes of this study evaluating abnormal alpha-synuclein in the nerves of the skin."

The study will enroll 75 patients with Parkinson's disease and 25 patients with REM Sleep Behavior Disorder (RBD) to further investigate the quantification of P-SYN in skin biopsies. This study will include longitudinal clinical assessments and biopsies to track the progression of phosphorylated alpha-synuclein accumulation in patients with Parkinson's disease. To ensure a diverse participant pool in the Syn-Q Study, CND will collaborate with approximately 25 clinical sites to enroll participants of different genders, racial backgrounds, and disease severity.

In March 2024, the Journal of the American Medical Association (JAMA) published results from a prospective, multicenter NIH-sponsored study evaluating Syn-One's ability to detect phosphorylated alpha-synuclein in cutaneous nerves. The study demonstrated that the Syn-One Test detected phosphorylated alpha-synuclein in 95% of patients with a clinical diagnosis of synucleinopathy, achieving a 92.7% positivity rate for patients with suspected Parkinson's disease. The Syn-One Test is also utilized in clinical development with pharmaceutical partners to better identify the patient population, quantify changes in synuclein deposition over time, and measure target engagement.

"We are excited to have the funding support of MJFF in our efforts to advance our Syn-One technology," said Christopher Gibbons, MD, Chief Scientific Officer, CND Life Sciences. "We believe this study will provide a foundational understanding of the natural progression of phosphorylated alpha-synuclein deposition in Parkinson's disease patients and support the ability to recognize who responds to treatment, assess therapeutic impact, and monitor disease progression."

About CND Life Sciences
CND Life Sciences supports the care of patients facing the potential diagnosis of neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND developed the Syn-One Test to help clinicians diagnose Parkinson's disease, dementia with Lewy bodies, and related disorders known as synucleinopathies. Syn-One uses proprietary immunofluorescence techniques to detect, visualize, and quantify phosphorylated alpha-synuclein in cutaneous nerves. Results of a recent prospective, multicenter NIH-sponsored study of the Syn-One Test were published in the Journal of the American Medical Association (JAMA) demonstrating >95% sensitivity in patients with a clinically determined synucleinopathy.¹ The test analyzes three small skin biopsy samples collected in a clinician's office through an in-office patient procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic markers. Approximately 2,000 neurologists and other clinicians in 49 states have used the Syn-One Test to support their diagnostic evaluation of patients. The Company also collaborates with biopharmaceutical companies on clinical trials for investigational therapies targeting neurodegenerative diseases and is conducting studies assessing the test's ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn.

¹Gibbons CH, Levine T, Adler C, et al. Skin biopsy detection of phosphorylated α-synuclein in patients with synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792.

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SOURCE CND Life Sciences