Regeneron joins Koneksa Parkinson's digital biomarker study

Regeneron is the second pharma group to sign up for access to data from a remote study run by health technology firm Koneksa that is exploring the use of digital biomarkers to track patients with Parkinson's disease.

The LEARNS trial – which started earlier this year – is using smartphone and wearable technologies to monitor disease progression in Parkinson's patients and find ways to use digital biomarkers in the development of disease-modifying therapies.

Regeneron has become a member of the data syndication programme for LEARNS, joining MSD/Merck & Co, which signed up in March, and will have real-time access to data and results from the study. Those can be used for "natural history analysis, trial design, cohort formation, and data analysis," according to the partners.

Quantitative tools for measuring progression are lacking in Parkinson's and other neurological disorders, with clinicians relying on subjective measures that make it harder to monitor patients, particularly as the rate of symptom decline fluctuates and varies wildly between individuals with the disease.

LEARNS is set to enrol up to 70 participants with Parkinson's who will be followed for 12 months, with first results expected next year. It uses the Koneksa neuroscience toolkit, which combines iPhone-based active assessments and passive monitoring using a wrist-worn wearable.

"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 chief executive.

"Our goal is to bring together biotech and pharma companies with real-time data sharing and analysis to expedite the validation and adoption of digital measures to unlock more data insights in clinical trials," he added.

Other projects looking at digital biomarkers for Parkinson's include the crowd-sourced DREAM Challenge, which saw 40 research teams from around the world contribute ways to process accelerometer and gyroscope data from consumer wearable devices that can be used to track muscle tremor, dyskinesia, and bradykinesia - three prominent symptoms of the disease.

Regeneron's pipeline doesn't currently include a clinical-stage treatment for Parkinson's. but it is working on drugs for other neurodegenerative disorders, including amyotrophic lateral sclerosis (ALS).

"At Regeneron, we believe that digital biomarkers have the potential to improve the development of novel therapeutics, and collaboration helps make this a reality," said the company's head of clinical development for genetic diseases, Gary Herman.

"Koneksa's data syndication community allows us to leverage collective expertise and gain insights that will inform future investigational therapies for Parkinson's disease."