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CND Life Sciences Building Evidence for Parkinson's Disease Skin Test


NEW YORK – Diagnostics firm CND Life Sciences has published new data detailing the performance of its Syn-One skin-based test for Parkinson's disease and other neurodegenerative disorders.

The Scottsdale, Arizona-based company is now set to close a $6 million Series A financing round to fund additional clinical studies including an ongoing longitudinal study of the test in patients at risk of developing Parkinson's.

CND's Syn-One test looks for the presence of phosphorylated alpha-synuclein (αSyn) in patient skin biopsies to aid in the diagnosis of Parkinson's disease and other neurodegenerative conditions like dementia with Lewy bodies.

Alpha-synuclein is a neuronal protein linked to Parkinson's and other neurological conditions. In Parkinson's patients, misfolded versions of αSyn form aggregates that accumulate throughout the brain in clumps called Lewy bodies that are believed to cause neuronal damage. The presence of phosphorylated αSyn in cutaneous nerve fibers also indicates the presence of the disordered αSyn behavior characteristic of these synucleinopathies.

"People with Parkinson's disease have a lot of disorders related to the autonomic nervous system," said Todd Levine, CND's cofounder and chief medical officer. "We were very interested in these autonomic nerves, and it turns out that the autonomic nerves are just below the surface of the skin. So, they're very accessible."

"We thought that there might be a way to visualize these autonomic nerves just by looking below the surface of the skin," Levine added. "And we began to look for this abnormal [phosphorylated αSyn] protein that turned out to be present in those nerves."

The test was developed by Roy Freeman and Christopher Gibbons, cofounders of the company and neurologists at Beth Israel Deaconess Medical Center in Boston, which licenses the technology underpinning the assay to CND. CND launched in 2017 and released the Syn-One test as a laboratory-developed test in 2019.

Levine said that the test has been used in roughly 20,000 people and that the company has around 1,200 neurologists who are actively using the test. He said that roughly 85 to 90 percent of tests performed have at least partial insurance coverage and that the company is a participating provider with Medicare and Tricare.

In the recent study, published this month in the Journal of the American Medical Association (JAMA), CND researchers and collaborators looked at results from the Syn-One test in 343 patients at 30 sites around the country, 223 of whom were diagnosed with a synucleinopathy and 120 of whom served as controls. The Syn-One test detected phosphorylated αSyn in 96 percent (213 of 223) of the subjects with any kind of synucleinopathy and 93 percent (89 of 96) of subjects with Parkinson's specifically.

Mark Frasier, co-CSO at the Michael J. Fox Foundation for Parkinson's Research, which was not involved in the study, said that based on the results, the Syn-One test shows comparable sensitivity to other approaches to diagnosing Parkinson's, such as alpha-synuclein seed amplification assays. In αSyn-SAAs, patient cerebrospinal fluid is introduced to a collection of healthy αSyn proteins. If aggregates form, it is an indication that the patient's CSF contains the misfolded αSyn characteristic of Parkinson's.

One area where Syn-One might seem to have an advantage is that samples are collected via skin biopsy (with three biopsies typically required) as opposed to the spinal tap required for αSyn-SAAs. Frasier said, however, that in his conversations with patients, a preference for one versus the other is not so clear-cut.

The other potential advantage of the Syn-One test is that it can provide quantitative information on the amount of phosphorylated αSyn in a sample as opposed to αSyn-SAAs, which provide a binary answer as to whether or not misfolded αSyn is present. Frasier said that based on the JAMA study it is difficult to say what level of quantitation the Syn-One test can provide but noted that "having a quantitative assay in skin or spinal fluid would be very valuable."

A quantitative assay could, for example, potentially let researchers track response to treatments or follow disease progression, Frasier said.

Levine said CND has developed a computer-assisted system called NerValence for detecting the presence of phosphorylated αSyn that could also improve the test's quantitative performance. The company developed the tool in collaboration with pathology firm Visiopharm and is currently using it in pharma trials.

"We do think we have the ability to quantitate [phosphorylated αSyn]," Levine said.

Frasier noted that despite developments in skin-based and αSyn-SAA testing, diagnosis of Parkinson's "is and will remain for the foreseeable future, based on clinical evaluation."

"Where I think these tests can be helpful are in certain individuals where the neurologists may not be certain and, particularly early in the disease, the symptoms may not be as apparent, and they may vary from day to day," he said.

Levine said that while CND initially expected Syn-One to be used primarily by general neurologists, use of the test thus far has been split roughly evenly between general neurologists and subspecialists, with the latter group often using the test to gain a bit of extra information that could be helpful in complicated or unusual cases.

The company is currently conducting two additional clinical studies for the test. In one, it is enrolling roughly 80 patients with isolated REM sleep behavior disorder (iRBD) — a risk condition for Parkinson's — at eight centers and following them over the course of two years and testing them with the Syn-One assay at baseline, one year, and two years to track test results and patient progression over time. The study will also collect additional biomarker, imaging, and clinical information to identify when patients convert to clinically apparent disease.

In the second study, CND is working with roughly 10 centers specializing in dementia and dementia with Lewy bodies (DLB) and will follow 40 patients with suspected mild cognitive impairment (MCI) due to DLB and 40 with suspected MCI due to Alzheimer's.

CND's $6 million Series A round, which Levine said will likely close mid-April, adds to the $12.5 million in seed financing the company has raised since its founding. Noting that the company has doubled sales of Syn-One every year since launching the test, he said the funding will go in part to continued commercialization efforts.

CND also has a number of active R&D programs the funding will help support, Levine said, noting that the company is looking for proteins in the skin beyond phosphorylated αSyn that could be diagnostically useful. It is also exploring whether other parts of the body, like the gastrointestinal system, could provide useful samples.

The company is also researching the possibility of detecting phosphorylated αSyn in blood, though Levine said this is made difficult by the large amounts of normal synuclein in blood cells and platelets.

"There are some newer techniques we're exploring that might allow us to do it," he said. "Obviously, that would be the big home run. But it's still very much in development."