Making Innovative Strides in Patient Mobility Outcomes

At 2 AM a woman living with multiple sclerosis (MS) gets out of bed. Simultaneously, a tone sounds in another room of the house to alert her caregiver and ensure her safety…

A young boy, recently diagnosed with Duchenne muscular dystrophy (DMD), longingly observes a boisterous game of tag on the playground…

A family prepares for their annual road trip to the beach, packing their vehicle to the brim – pointedly saving space for a beach-accessible wheelchair…

Conditions that impair movement and motor function, including MS, DMD, Huntington’s disease or even Parkinson’s disease, among many others, vary in cause but all significantly impact patients, their caregivers and their families. From the physical demands of daily activities, doctor visits,?feelings of anxiety and isolation to financial obligations for condition management, the impacts of impaired motor function affect roughly 36 million people in the US alone, according to a?2020 estimate from the US Centers for Disease Control and Prevention.

Disease progression and treatment efficacy are currently assessed using in-clinic evaluations of movement (e.g., standard tests including the 6-minute walk test or 10-meter?walk/run test). These assessments generate meaningful data, but don’t account for potentially significant condition changes in between patient visits. The limitations of discrete data collection can result in prolonged trial durations to accumulate necessary data for novel treatments to demonstrate therapeutic effects based on these traditional endpoints.?

For patients with serious mobility impairments, visits to medical facilities require significant time and coordination, adding additional physical, mental and emotional stress. This, in addition to geographical limitations, can impact patient recruitment efforts for clinical trials. These challenges in data collection and patient recruitment ultimately impact clinical timelines, which can delay development and commercialization of innovative new therapeutic options.

There’s a better way.

A Breakthrough in Digital Health Technology

Improvements in data collection and computing technologies have made patient monitoring in real life and utilization of digital regulatory endpoints achievable. Captured by a wearable sensor worn by the patient to accumulate clinically meaningful, real-world motion data, these digital endpoints can drive efficiencies in clinical research and improvements in patient care to ultimately improve overall motor function in daily life for patients and minimize the constraints of drug development.?

For patients, this means collection of meaningful data without interrupting daily activities, while clinicians can obtain precise, reliable and more robust data compared to current standard measures. Payers and regulators can reliably assess therapeutic efficacy by analyzing patient motor function, and drug developers can design more efficient trials with smaller study cohorts, shortened durations and fewer trial sites. Healthcare providers can access meaningful data to better monitor and treat disease, while enabling a more personalized treatment approach.?

Pioneering a Transformative Solution

Uniquely equipped with a full spectrum of assets to support advances in motion capture for digital health, Sysnav Healthcare is the first company to secure the qualification of a digital endpoint (stride velocity 95th centile, or SV95C) with the European Medicines Agency (EMA) for DMD as representative of patient motor function.?

Data presented to the EMA for the DMD population examined indicate that demonstrating stabilization of motor function in a clinical setting with the 6MWT (a DMD “gold standard”) would require data collection from 113 patients over 12 months. Employing SV95C, researchers can achieve the same statistical power from only 23 patients in 6 months: a nearly 80% reduction in patient cohort size and a 50% reduction in study duration. Given this transformative potential to make clinical evaluation of novel therapeutics more efficient, Sysnav Healthcare has filed an application for qualification of SV95C as a primary endpoint with the EMA for DMD, with a decision expected in Q1 2023.?

Now is the time to evolve how mobility outcomes are measured. We founded Sysnav Healthcare to unlock the potential of real-world medical data by adapting precise motion-capture solutions to the needs of healthcare professionals and patients. We have made significant progress toward this goal and through collaborations like our?recently announced partnership expansion with Roche, we continue to progress the validation and standardization of digital endpoints.?

Each stride we make toward re-evaluating current standards, applying innovative research technologies, and adopting improved standards of care represents a massive step toward transforming the lives of patients around the globe – and that is a future we at Sysnav Healthcare are proud to strive for.?