Regeneron joins data program for LEARNS digital biomarkers trial
Company gains immediate, continuous access to data, results
Regeneron has joined the data syndication program for Koneksa‘s LEARNS study that’s assessing the potential of digital biomarkers for measuring the progression of Parkinson’s disease.
The program enables Regeneron to gain immediate and continuous access to data and results as the trial progresses, which may accelerate the adoption of digital measures into the company’s own clinical efforts.
Regeneron is the second participant in the data syndication program, following Merck (known as MSD outside the U.S. and Canada), which joined in March.
“At Regeneron, we believe that digital biomarkers have the potential to improve the development of novel therapeutics, and collaboration helps make this a reality,” Gary Herman, MD, senior vice president for early clinical development and experimental sciences at Regeneron, said in a Koneksa press release. “Koneksa’s data syndication community allows us to leverage collective expertise and gain insights that will inform future investigational therapies for Parkinson’s disease.”
LEARNS is a longitudinal, observational study designed to determine the usability of digital biomarkers, such as those measured with mobile electroencephalogram (EEG), wearable devices, and smartphone-based assessments, in sleep and neurological disorders. EEG measurements allow researchers to monitor the brain’s electrical activity and find evidence of neurological issues.
Capturing data in a more convenient way
“This syndicate model, which fosters community building, has been proven to accelerate the validation and adoption of new measures,” said John Wagner, MD, PhD, chief medical officer at Koneksa. “We’re bringing speed and precision to evidence generation, expediting the integration of superior measures in trials and post-marketing surveillance.”
The trial will involve people with a number of conditions, including obstructive sleep apnea, Alzheimer’s disease, and mild cognitive impairment.
The Parkinson’s portion of the trial (NCT06219629) looks to recruit up to 70 adults with Parkinson’s disease, ages 18 to 85, who will be followed for 12 months. Enrollment is open at several clinical sites in the U.S.
The study’s main goal is to track disease progression using a set of parameters captured remotely with the Koneksa Neuroscience Toolkit, which includes iPhone-based assessments from patients and data collected with a wrist-worn device. The findings are expected to inform the development of digital biomarkers for disease progression.
The goal is to capture more objective and frequent measures that reflect Parkinson’s progression in a more convenient way than conventional assessments, which may help doctors adjust treatment earlier. “We encourage this community-based approach and believe the appropriate use of evidence-based digital measures in clinical trials can help ensure robust and reliable data collection,” said Herman.
“Detecting the earliest signs of Parkinson’s disease and establishing the necessary evidence of validity for new measures are critical needs within the healthcare community,” said Chris Benko, Koneksa’s CEO.
Pharmaceutical and biotech companies interested in joining the syndication program can contact Koneksa.
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