NEW YORK--(BUSINESS WIRE)--Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, announced today that Regeneron has become a member of its Data Syndication Program for the LEARNS observational study. This study aims to remotely measure disease progression using digital biomarkers in neurodegenerative disorders. As a member, Regeneron will have real-time access to the deidentified study data, study monitoring, and analysis results.
“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, CEO, Koneksa. “We’re gaining momentum with the addition of Regeneron to our syndication. 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.”
The Koneksa-led clinical validation study initially focuses on a 12-month disease progression assessment with up to 70 Parkinson’s disease patients. Remote disease measurement through digital biomarkers offers the opportunity to capture disease dynamics and impacts in daily life more conveniently.
“At Regeneron, we believe that digital biomarkers have the potential to improve the development of novel therapeutics, and collaboration helps make this a reality. Koneksa’s data syndication community allows us to leverage collective expertise and gain insights that will inform future investigational therapies for Parkinson’s disease,” said Gary Herman, M.D., Senior Vice President, Clinical Development Unit Head, Genetic Medicines. “As leaders in innovative drug development, 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.”
“This syndicate model, which fosters community building, has been proven to accelerate the validation and adoption of new measures,” said John Wagner, M.D., Ph.D., Chief Medical Officer, Koneksa. “We're bringing speed and precision to evidence generation, expediting the integration of superior measures in trials and post-marketing surveillance.”
At Koneksa, the value of new digital measures is underscored by the quality and depth of data analysis defining them. The precision of longitudinal digital data combined with in-clinic data from this study creates a robust resource for natural history analysis, trial design, cohort formation, and data analysis.
The syndication model offers program participants immediate and continuous access to data and results under a perpetual use license agreement for research, development, and regulatory purposes. Real-time study monitoring via Koneksa’s proprietary platform provides visibility into the efficacy of site coordinator tools, ensuring participant support and over 80% compliance in both clinical and home settings over extended studies. Syndication program participants gain immediate insights from the study dashboard and data, positioning them at the forefront of adopting new measures in their research endeavors.
“Digital biomarkers are reshaping drug development, and we're providing the evidence and community for these pioneering methodologies,” said Dave Hurry, Chief Data Officer, Koneksa. "Koneksa Data Syndication offers participants the agility of an independent study coupled with the rigor and cost-effectiveness of pre-competitive collaborations.”
Regeneron joins Merck, the first program participant to join the data syndication program in March 2024.
For more information about joining our data syndication program, contact Koneksa: datasyndication@koneksahealth.com. More information on the LEARNS study is available at clinicaltrials.gov (NCT06219629).
About Koneksa
Koneksa is a healthcare technology company pioneering evidence-based digital biomarkers to accelerate clinical research and guide decision-making in drug development and market strategy. Our evidence-based biomarker solutions enable efficient clinical trial designs to help innovative therapies reach patients faster. Koneksa aims to revolutionize treatment effect detection in clinical research and improve patient outcomes. Learn more at koneksahealth.com.
