Bayer subsidiary BlueRock Therapeutics has entered partnerships with two digital health companies to evaluate remote monitoring technologies that could transform clinical trial design for Parkinson's disease treatments. The company signed agreements with Rune Labs and Emerald Innovations to test whether digital biomarkers can improve data collection for its experimental stem cell therapy bemdaneprocel (BRT-DA01).
Digital Monitoring Technologies Target Real-Time Symptom Tracking
The collaboration with Rune Labs centers on the StriveStudy platform, which connects with Apple Watch and specialized software to measure movement disorders. The system records symptoms including general mobility, tremor intensity, dyskinesia, and involuntary muscle movements in real-time, providing continuous monitoring capabilities that traditional clinical assessments cannot match.
BlueRock has also partnered with Emerald Innovations to access its "invisible" biosensor technology. The device, positioned in a room like an Internet router, generates and monitors radio wave patterns in the home to detect movements and sleep quality continuously. Artificial intelligence interprets the data, which is automatically uploaded to the cloud without requiring patients to wear any devices.
Addressing Clinical Trial Limitations in Parkinson's Disease
"Parkinson's disease is incredibly complex, with symptoms often varying hour to hour through the course of the day," said Seth Ettenberg, BlueRock's chief executive. "New tools and approaches are needed to ease the reporting burden on patients in trials and to measure and assess disease progression more effectively."
Current Parkinson's monitoring relies primarily on subjective patient-reporting tools such as diaries and questionnaires, supplemented by periodic neurological and mobility assessments that only capture symptoms at specific moments in time. The digital approach aims to provide comprehensive, objective data that could enable studies to generate results more quickly while improving the quality of study outcomes.
Stem Cell Therapy Development Continues
BlueRock's bemdaneprocel represents a first-in-class therapy designed to target the underlying cause of Parkinson's disease. The treatment is administered through surgical transplantation into the putamen, a brain region where dopamine-producing cells are grafted to restore depleted neurotransmitter levels characteristic of the disease.
Patients receiving bemdaneprocel also take immune-suppressing drugs for one year to prevent transplant rejection and are monitored for two years to assess safety and symptom effects. Phase 1 results from an initial cohort of 12 patients are expected later this year.
Initial Digital Health Validation Study
The digital health technologies will first be evaluated in a non-interventional study involving 50 subjects to determine their performance compared to current monitoring and data collection methods. If successful, real-time monitoring could be integrated into future bemdaneprocel clinical trials as the therapy advances through development.
Additionally, BlueRock is conducting a separate 500-patient, two-year non-interventional study comparing different frequencies of diary-based monitoring in Parkinson's patients to optimize traditional data collection approaches.
Growing Adoption of Digital Biomarkers
The initiative reflects broader industry trends toward incorporating connected and wearable sensors in neurological clinical trials. According to recent research, the number of studies using digital health technologies increased approximately 39% annually between 2010 and 2020, with around 8% of Parkinson's trials utilizing these approaches by the end of the study period.
The hope is that gathering real-time data from trial subjects will allow studies to generate results in shorter timeframes while improving the overall quality of clinical research outcomes in this complex neurological condition.
