Michael J. Fox Foundation awards $4.2M to support clinical trial of Parkinson’s skin test

A Phoenix-area medical technology company has received $4.2M grant fromThe Michael J. Fox Foundation for Parkinson’s Research to support a study for a skin test that quantifies abnormal alpha-synuclein in those with Parkinson’s disease.

According to a press release from manufacturer CND Life Sciences, its Syn-One Test is a skin biopsy assay that utilizes immunofluorescence to detect and visualize phosphorylated alpha-synuclein (P-SYN) in cutaneous nerves.

The test makes its determination by analyzing three small skin biopsy samples which are collected in a clinical setting, the company said.

"We are excited to partner with [Michael J. Fox Foundation] on this important study in patients living with Parkinson’s disease,” Chris Gibbons, MD, CND Life Sciences chief scientific officer, told Healio in an email. “Patients will be reevaluated at 6-month intervals to quantify the amount of misfolded alpha-synuclein detected in nerves in the skin at each time point. This will enable researchers to assess disease severity over time and measure target engagement in drug discovery.”

The pending clinical trial is expected to enroll 75 patients with Parkinson’s along with 25 individuals diagnosed with REM Sleep Behavior Disorder. This study will include longitudinal clinical assessments and biopsies to track the progression of P-SYN accumulation in patients with PD.

According to data cited in the release, results of a prospective, multicenter, NIH-sponsored study published in the March edition of JAMA found Syn-One was able to detect P-SYN in 95% of those diagnosed with synucleinopathy, along with a 92.7% positivity rate for patients with suspected PD.