Rune Labs, a precision neurology software and data platform company, announces it is enrolling patients with multiple sclerosis (MS) in a study to identify neurophysiological biomarkers of the disease. The company has partnered with Coastal Research Institute (CRI) to measure demyelination in patients with spinal cord stimulators using closed loop technology. Demyelination is a hallmark symptom of MS that occurs when the immune system attacks nerve fibers, causing lesions in the brain and spine. 

More remyelination therapeutics are entering the clinic, but there are no biomarkers that measure a patient’s degree of myelination, making it difficult to assess a drug’s efficacy. Clinical scores currently used as endpoints and screeners in trials are imprecise and do not always correlate with lesion activity. Other approaches like imaging and measuring optic nerve electrophysiology only apply to a subset of patients with specific symptoms.

“By taking advantage of access to the spinal cord provided during routine clinical procedures, this study will capture precise neurophysiological data and measure myelination using a variety of evoked potentials,” said Ro’ee Gilron, Rune Labs’ lead neuroscientist. “Rune’s AI platform enables us to take raw brain data and convert it into actionable biomarkers of myelination.”

With the study, Rune Labs and CRI aim to develop a MS metric that is sensitive to the degree of myelination and can be used to augment a clinical score. The partners are enrolling MS patients who will receive a spinal cord stimulator, a common implant to reduce neuropathic pain. Rune Labs will be able to record electrophysiological signals from the spinal cord and cortex, measuring the underlying physiology tied to myelination.

Clinical metrics of MS severity (EDSS) used today are non-linear, fluctuate widely at lower levels, are stagnant at higher scores, and mostly focus on mobility metrics. The partners are developing a more sensitive metric to better capture the heterogeneity of MS presentation.

“Currently, clinicians have no easy way to measure myelination in patients with multiple sclerosis,” said Krishnan Chakravarthy, MD, PhD, CRI Co-Founder and Executive Director, and adjunct faculty of UCSD Center for Nanoengineering. “If we’re going to develop effective disease-modifying therapies, and design and run more efficient clinical trials that capture efficacy signals, we’ll need precise, non-invasive biomarkers that measure the degree of myelination and reflect disease pathology.”

Rune Labs’ first-in-class precision neurology software platform uses machine learning to capture and analyze electrophysiological brain data to uncover previously overlooked markers of disease. This provides researchers and drug developers with novel biomarkers to design more efficient clinical trials and develop better-targeted therapies.

[Source(s): Rune Labs, PR Newswire]