CND Life Sciences, an innovative medical diagnostics company pioneering the detection, visualization, and quantification of protein deposition in cutaneous nerve fibers, has been awarded a $3 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). This is the third NIH SBIR Phase II award for the company to study and advance the clinical application of the Syn-One Test, the only commercially available test that uses skin biopsies to help clinicians diagnose a synucleinopathy, a family of neurodegenerative diseases that includes Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA), pure autonomic failure (PAF) and REM sleep behavior disorder (RBD).
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RBD is one of the earliest pre-motor manifestations of neurodegenerative disease and is often present 10-15 years prior to diagnosis of PD, DLB or MSA. Patients diagnosed with RBD experience vivid, often disruptive dreams associated with simple or complex motor behavior during the REM phase of sleep. According to scientific literature, it is estimated that approximately 1% of the general population and 2% of older adults have RBD, and a majority of these individuals are at risk of converting to another synucleinopathy in their lifetimes.
“The results from this study could greatly expand the possibilities for Syn-One as a cutaneous neurodiagnostic test, as we explore the utility of identifying phosphorylated alpha-synuclein deposition in the prodromal stage of neurodegenerative diseases,” said Todd Levine, MD, CND’s Chief Medical Officer and principal investigator for the study. “Synucleinopathies represent a devastating group of diseases that evolve over many years and even decades. Being able to detect phosphorylated alpha-synuclein in patients with RBD could allow us to treat and even prevent debilitating diseases like PD and DLB before they fully develop. The success of future treatments for these disorders will be tied to how precisely and early we can understand the patient’s pathology,” explained Levine.
CND’s Syn-One Test uses three small skin biopsies, conveniently collected from a patient in a physician’s office, to accurately detect and visualize the presence of misfolded, phosphorylated alpha-synuclein, the abnormal form of a naturally-occurring protein that is the pathological hallmark of the synucleinopathies including RBD.