BlueRock Therapeutics to incorporate wearable and invisible contactless digital health technologies from Rune Labs and Emerald Innovations in Parkinson's disease clinical trial
Rune Labs' StriveStudy platform and Emerald Innovations' Emerald wireless monitoring sensor will passively capture data on Parkinson's disease impact on function of fifty study participants in BlueRock's global non-interventional clinical study.
Collaboration is part of BlueRock's commitment to change the standard of care for treating Parkinson's disease which includes a first-in-class stem cell-based therapy bemdaneprocel (BRT-DA01), currently in a phase 1 clinical study. Results from the Phase 1 study are expected to be announced in the second half of 2023.
CAMBRIDGE, Mass., March 14, 2023 /PRNewswire/ -- BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned, independently operated subsidiary of Bayer AG, today announced a collaboration with Rune Labs and Emerald Innovations focused on using wearable and invisible contactless digital health technology to improve monitoring and data collection for Parkinson's disease clinical trials.
Currently, monitoring and data collection in Parkinson's disease clinical trials combine subjective patient-reporting tools such as diaries and questionnaires with periodic neurological and mobility assessments in a clinical setting that only capture a specific moment in time. Unfortunately, this approach fails to give a full, real-time picture of disease progression and the impact of a patient's daily experience with Parkinson's symptoms such as uncontrolled tremors and muscle movement, rigidity, restless sleep and loss of balance.
"Parkinson's disease is incredibly complex, with symptoms often varying hour to hour through the course of the day," said Seth Ettenberg, President and CEO of BlueRock Therapeutics. "New tools and approaches are needed to ease the reporting burden on patients in trials and to measure and assess disease progression more effectively. We are excited to be working with the pioneering teams at Rune Labs and Emerald Innovations to harness the power of their digital health technologies to collect an unbiased, objective, and continuous measure of disease impact on function that will help us develop more effective therapies."
BlueRock is working to change the standard of care for treating Parkinson's disease and is currently testing a first-in-class stem cell-based therapy, bemdaneprocel (BRT-DA01), in a Phase 1 clinical study. Results from the Phase 1 study are expected to be announced in the second half of 2023. The company is also enrolling patients in a two-year global non-interventional study focused on gaining a better understanding of patients' day to day experience with Parkinson's disease.
In the non-interventional study, the Rune Labs and Emerald technologies will be used to monitor the daily activities and measure key markers of disease progression in 50 patients and monitor their daily activities.
Rune Labs' StriveStudy platform works directly with the wearable Apple Watch and Apple's Movement Disorder API and will be used to record real-time measurement of general mobility, tremor intensity, dyskinesia, and involuntary muscle movements of patients in the non-interventional study. BlueRock can leverage StriveStudy to monitor patient compliance by tracking how often they wear the Apple Watch in the study, as well as to improve the study experience for patients by streamlining data collection
"This collaboration is shifting the paradigm for Parkinson's disease drug development," said Brian Pepin, CEO of Rune Labs. "To give hope to Parkinson's patients, we need to push neurology drug development into the future, and we believe that Rune Labs' precision neurology platform can support this goal, much as precision medicine pioneers drove the oncology field forward."
Emerald Innovations' Emerald monitoring biosensor belongs to a new class of sensors called "invisibles" that extract health metrics from radio signals, without wearable devices. Placed in the homes of study participants, the Emerald sensor continuously analyses the surrounding radio signals using artificial intelligence. In this study it will collect data on patients' gait speed, mobility, and sleep quality.
"Emerald is built on a decade of research and has demonstrated strong correlation with the gold standards in Parkinson's, while allowing clinical trials to reach robust evidence faster and with a smaller number of patients. Our collaboration with BlueRock enables a data-driven clinical trial in Parkinson's while patients go about their normal lives," said Dr. Dina Katabi, Co-Founder of Emerald Innovations.
BlueRock will compare data from the use of both technologies to standard measurement and feasibility tools to gauge the feasibility of their use for future clinical studies for bemdaneprocel (BRT-DA01).
About the bemdaneprocel (BRT-DA01) Phase 1 Trial
In the United States, the trial was initiated at Weill Cornell Medicine with Dr. Harini Sarva, M.D. as the Principal Investigator (PI) and first surgeries being performed by Dr. Viviane Tabar, Chair of the Department of Neurosurgery at Memorial Sloan Kettering Cancer Center. Dr. Tabar has financial interests related to BlueRock. Memorial Sloan Kettering (MSK) has institutional financial interests related to BlueRock. Additional Neurology sites were added at the University of California, Irvine, under the guidance of Dr. Claire Henchcliffe, M.D., D.Phil., F.A.A.N., F.A.N.A. (PI), and at the University Health Network (UHN), under the guidance of Dr. Lozano, O.C., M.D., Ph.D., F.R.C.S.C., F.R.S.C., F.C.A.H.S. (PI) and Dr. Alfonso Fasano, M.D., PhD., Chair in Neuromodulation and Multi-Disciplinary Care, UHN and UoT.
More information about the Phase 1 trial is available at clinicaltrials.gov (NCT#04802733)
More information about the non-interventional study is available at clinicaltrials.gov (NCT#05363046)
About Parkinson's Disease
About BlueRock Therapeutics LP
Forward Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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