Cumulus Neuroscience to Partner with The Digital Medicine Society (DiMe) to Drive Adoption of Digital Endpoints in Clinical Trials

Cumulus to participate in The Digital Health Measurement Collaborative Community (DATAcc) by DiMe project – Building the Business Case for Digital Endpoints – to establish industry benchmarks for evaluating return on investment when utilized in the development of drugs, medical devices, and other regulated interventions.

BELFAST, Northern Ireland and CAMBRIDGE, Mass., June 11, 2024 /PRNewswire/ -- Cumulus Neuroscience (Cumulus; The Company), a global digital health company focused on advancing neuroscience clinical trials and patient care through improved data, today announced a partnership with the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe).

Cumulus will participate in the DATAcc by DiMe Building the Business Case for Digital Endpoints project, which will convene leaders from across the field to establish shared industry benchmarks for evaluating the return on investment (ROI) of digital endpoints in the development of drugs, medical devices, and other regulated interventions. Outputs of the project will include a value framework, industry benchmarking tools, ROI forecasting models, and a modular template to support innovators developing the business case for digital endpoints in the development, implementation, and scale of fit-for-purpose digital measures as endpoints in clinical trials.

"The value of using digital measures in clinical research is significant, but still adopters often struggle to make the case for broader use," said Victoria Bangieva, PhD, Program Director DiMe. "At DiMe, we're committed to advancing the use of digital health measures in research to improve lives, and we value the contribution from key partners like Cumulus Neuroscience to develop resources that will help drive the industry towards increased utilization."

Previously, Cumulus participated in the DATAcc by DiMe Library of Digital Endpoints project, which established the only library specifically focused on industry-sponsored studies of new medical products or applications. This one-of-a-kind library is continuously updated, intended to be both a reference resource and a transparent library that DATAcc partners help build and maintain.

As an extension of this project, multiple industry stakeholders, including Cumulus, collaborated on a comprehensive landscape analysis to identify digital health technologies for Alzheimer's disease and related dementia populations. The analysis collated peer-reviewed manuscripts, poster presentations, and regulatory documents for 106 different technologies. The results of this analysis – "Digital Health Technologies for Alzheimer's Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort" – appear in the June 2024 issue of the Journal of Prevention of Alzheimer's Disease.

"In CNS clinical studies, many endpoints are tied to traditional pen and paper assessments, which lack any objective physiological data, impacting researchers' ability to efficiently establish drug effect, drug target engagement and inform patient stratification," said Aman Bhatti, MD, CEO Cumulus Neuroscience. "We engage regularly with digital endpoint champions within biopharma companies who understand the limitations of traditional tools, yet often face difficulty gaining support and budget to enable the inclusion of digital endpoints, which have the potential to address many of these well understood challenges. We are honored to work alongside DiMe and their industry partners to develop tools that will be instrumental in achieving our shared goal of advancing the acceptance and utilization of digital endpoints across therapeutic areas."

Cumulus supports precision in CNS clinical trials for its industry partners by enabling in-clinic and remote monitoring of patients across multiple domains of brain function. To learn more, visit www.cumulusneuro.com.

About Cumulus Neuroscience
With a mission to generate the data and insights required to accelerate diagnosis and management of central nervous system (CNS) disorders for millions of patients and caregivers around the world, Cumulus Neuroscience is advancing NeuLogiq™, an AI-based, multi-domain digital biomarker platform to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care. Designed for and with 10 of the world's leading pharma companies, the platform enables decentralized trials, and is already making a difference in the development of therapies for Alzheimer's Disease, depression, and schizophrenia.

Designed to provide an industry-wide standard for real-world measurement of disease progression, Cumulus combines patented technology, in-house expertise, and key industry partnerships to capture large amounts of real-world, clinical data repeated over time, across multiple behavioral and physiological domains in the patient's home – all with an EEG headset synced to a novel, tablet-based neuro-assessment platform. Together with machine learning (ML) analytics and the world's largest database of annotated, longitudinal, neurofunctional data, Cumulus simplifies and improves the robustness of neuroscience clinical trials to provide the best and most cost-effective assessment of CNS treatment outcomes.

The Company is supported by highly experienced specialized investors, DDF/SV Health Investors, LifeArc and Future Fund, and a world-class Scientific and Technical Advisory Board.

FOR MORE INFORMATION
Julie Dietel
FINN Partners for Cumulus
julie.dietel@finnpartners.com
Tel: 978.502.7705

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