Digital tech assessed in BlueRock Parkinson’s trial
Bayer subsidiary BlueRock Therapeutics is evaluating digital health technologies that it hopes could support the development of its stem cell-based therapy for Parkinson’s disease, currently in early-stage clinical testing.
BlueRock has signed agreements – with Rune Labs and Emerald Innovations – for a pair of technologies that will be used to remotely capture data from patients to see if they can improve monitoring and data collection for future clinical trials of Parkinson’s disease candidates.
The company has a direct interest in this area with bemdaneprocel (BRT-DA01), billed as a first-in-class therapy that could target the underlying cause of Parkinson’s.
The deal with Rune Labs focuses on its StriveStudy platform, which connects with Apple Watch and its software to measure movement disorders to record symptoms like general mobility, tremor intensity, dyskinesia, and involuntary muscle movements in real-time.
BlueRock, meanwhile, has also called on Emerald for access to its eponymous biosensor, from a new class of “invisible” sensors that can harvest health data from patients without the need for a wearable device.
The device – which is placed in a room in much the same way as an Internet router – generates and monitors radio wave patterns in the home, detecting the movements and sleep quality of people continuously, interpreting the data with artificial intelligence, and uploading the findings automatically to the cloud.
The hope is that gathering data from trial subjects in this way will allow studies to generate results in a shorter period of time, and improve the quality of study results.
The initial trial of the digital health technologies is a non-interventional study in 50 subjects that is intended to see how well they perform as an alternative to current monitoring and data collection tools for Parkinson’s.
Those rely mainly on subjective patient-reporting tools, such as diaries and questionnaires, backed up with periodic neurological and mobility assessments that only provide a snapshot of a patient’s symptoms in a specific moment in time.
The hope is that real-time monitoring could be used in bemdaneprocel studies if it progresses further in development. Phase 1 results with the stem cell therapy in an initial cohort of 12 patients are due later this year.
Meanwhile, BlueRock is also running a 500-patient, two-year, non-interventional study to compare different frequencies of diary-based monitoring of Parkinson’s patients, to see which works better.
“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.”
Bemdaneprocel is administered by surgical transplantation into part of the brain known as the putamen, in the hope of grafting dopamine-producing cells that can bolster the depleted levels of the neurotransmitter seen in Parkinson’s.
Patients also take immune-suppressing drugs to prevent rejection of the transplant for a year, and will be followed for two years to gauge its safety and effects on symptoms.
The new study ties into accelerating use of connected and wearable sensors to improve data collection in clinical trials in neurology, with the number of studies using this type of technology rising around 39% a year between 2010 and 2020, according to a recent study.
It found that around 8% of Parkinson’s trials were using digital health technologies by the end of the study period.