14 Jul, 2022, 08:00 ET
Quantitative biomarkers of demyelination can improve clinical trial design and accelerate development of disease-modifying therapeutics
SAN FRANCISCO, July 14, 2022 /PRNewswire/ -- Rune Labs, a precision neurology software and data platform company, today announced 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 today's 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.
Rune Labs is a software and data analytics company for precision neurology, supporting care delivery and therapy development. StrivePD is the company's care delivery ecosystem for Parkinson's disease, enabling patients and clinicians to better manage Parkinson's by providing access to curated dashboards summarizing a range of patient data sources, and by connecting patients to clinical trials. For therapeutics development, biopharma and medical device companies leverage Rune's technology, network of engaged clinicians and patients, and large longitudinal real-world datasets to expedite development programs. The company has received financial backing from leading investors such as Eclipse Ventures, DigiTx, TruVenturo and Moment Ventures. For more information, please visit www.runelabs.io.
Coastal Research Institute was founded to foster clinical and research excellence worldwide. With partners both in the US and Australia the Institute founded by physicians focuses on clinical research excellence that includes site training, quality data collection, timely clinical study completion and research excellence in new technology development as well as clinical trials in the device and pharmaceutical specialties. A multidisciplinary and diverse leadership enables services that include study design, execution, data analysis, and publication. The institute continues to contribute to the global discourse in the field of neuroscience and pain medicine and is a leading premiere research institute in Southern California.
Consort Partners for Rune Labs
SOURCE Rune Labs
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