Dear Friends,
As the year comes to a close, we are grateful for the progress we have made toward our vision of developing digital measures that benefit patients and are excited to share our accomplishments with you.
In 2024, we made significant strides in expanding our capabilities and datasets for verifying and validating new digital tools and measures across multiple diseases. A key milestone was the completion of our state-of-the-art 350 m² digital health laboratory, fully equipped for device verification and the analytical validation of novel digital measures along with the collaborative development of new protocols for device verification and validation. Additionally, we furthered the field of digital measure development through several publications with our collaboration partners:
- Key considerations for implementing DHTs in clinical trials with the Critical Path Institute eCOA Consortium
- Regulatory pathways for qualification and acceptance of DHT derived endpoints with FNIH
- V3+ framework; Systematic review of human factors of sensor-based DHTs; and Meaningful aspects of physical activity with the Digital Medicine Society (DIME)
With our deep expertise in building digital measures, Koneksa is proud to be leading the charge in the analytical and clinical validation of digital measures for Parkinson’s Disease (PD). This year, Koneksa started our LEARNS study, which focuses on measuring the reliability and responsiveness of digital biomarkers for neurodegenerative conditions like PD and allows for remote monitoring that captures disease progression in patients’ daily lives. The clinical study is conducted using a newly emerging syndication model, which is a hybrid of single sponsor and precompetitive collaboration. This curated collaboration involves the partners Merck and Regeneron, and is open to additional partnership. Additionally, we presented study design considerations for digital assessments in Parkinson’s disease clinical trials at the 2024 ISPOR conference and published our findings in Frontiers in Digital Health. We also presented results from reprocessing data from a clinical validation study using the mPower app and conducting interim analyses in two MJFF-funded projects exploring the clinical validity of wearable and speech-derived measures.
Beyond neurodegenerative conditions, Koneksa is committed to developing digital models that can be used across a number of conditions and exploring the benefits of DHTs in rare diseases. We recently concluded our LEARNT clinical study supporting a multi-domain model for capturing functional status through connected digital tools, emphasizing the utility of continuous 24/7 functional status measures. This innovative digital model utilizes digital health technologies to enhance assessments of patients’ physical, cognitive, and behavioral functioning, addressing limitations of traditional methods. The model includes four key domains: physical activity, vital signs, sleep variables, and health-related quality of life, enabling high-resolution data collection in real-time, and may become useful in a number of diseases including cancers. In the realm of rare diseases, we presented with Amicus at the WORLDSymposium on how cardiac biomarkers can help drug development in Fabry disease.
We are excited to share more about these advancements in publications and conference presentations in 2025, and you can follow us on LinkedIn to stay up-to-date. Please reach out if you are exploring digital measures for an upcoming project. Our scientific team is ready to support you in developing a plan for digital measures in your study.
Have a wonderful holiday season and we look forward to connecting with you in the New Year.