EMA opinion marks the first qualification of a digital outcome measure for use as a primary endpoint in pivotal drug trials
SV95C is an objective, real-world digital ambulation measure of top performance, informing more confident treatment decision-making and streamlining drug development, with potential to shorten trial durations or decrease enrollment requirement
VERNON, France, Aug. 8, 2023 /PRNewswire/ -- SYSNAV Healthcare announces that the European Medicines Agency (EMA) considers that for ambulant Duchenne Muscular Dystrophy (DMD) patients four years of age and above, Stride Velocity 95th centile (SV95C) qualifies as primary endpoint in superiority studies as an alternative to the 6 Minute Walking Test (also called 6 Minute Walking Distance) provided this outcome measure is supported by consistent findings in established efficacy endpoints included in secondary endpoints. SV95C is the first digital endpoint that has been qualified by a regulatory agency for use as a primary endpoint in pivotal studies.
This achievement is the result of a fourteen-year collaboration between many stakeholders across the DMD community, including technology developers, academia, the pharmaceutical industry, caregivers, and most importantly patients and families living with DMD.
DMD is a rare and progressive neuromuscular disease causing muscle weakness that renders the majority of patients wheelchair dependent by the age of 13. While there is significant promise in new therapy development for Duchenne, measuring the impact of an intervention can be difficult due to the heterogeneity of disease progression. Pat Furlong, president of Parent Project Muscular Dystrophy, commented: "It is critical to measure treatment efficacy objectively and rigorously. SV95C is this piece of the puzzle, a real-world digital endpoint that has the potential to decrease the duration of studies, lower enrollment requirements, and advance the approval process."
"We truly believe in the transformative impact of digital endpoints in clinical development - enabling better measurement of the functional ability of DMD patients and to assess potential treatment benefits more objectively and reliably. The digital endpoint SV95C has the potential to shorten clinical trial duration or decrease the number of patients," said Damien Eggenspieler, SYSNAV Healthcare program director. The contribution of the long-lasting industry partner Roche was critical to the regulatory qualification of SV95C. SYSNAV and Roche recently signed a partnership to expand regulatory approved endpoints beyond DMD to several priority diseases from their portfolio, in partnership with the patient communities.
About SV95C
SV95C is a digital outcome measure of peak ambulatory performance of patients captured during normal daily living. It provides an accurate and clinically meaningful insight into real-world functional ability of patients and measures the progression of their disease or efficacy of therapies. SV95C can be captured to a regulatory standard by the ActiMyo® and Syde® wearable devices, based on SYSNAV's proprietary wearable technology and analytical methodology. As an objective and real-world endpoint, SV95C addresses many of the limitations of traditional endpoints currently used in clinical trials in DMD. The EMA considers that for ambulant DMD patients four years of age and above, SV95C qualifies as primary endpoint in superiority studies as an alternative to the 6 Minute Walking Test (also called 6 Minute Walking Distance) provided the outcome measure is supported by consistent findings in established efficacy endpoints included as secondary endpoints.
About SYSNAV Healthcare
SYSNAV Healthcare is a leading business unit of SYSNAV, a fast-growing French independent tech company. Since the start of its activities, SYSNAV Healthcare aims to unlock the potential of real-world data in the medical field by adapting extremely precise motion-capture solutions to the needs of healthcare professionals and patients. The company has developed two wearable devices, ActiMyo® & Syde®, and is the first-ever to qualify a digital endpoint (SV95C) with the European Medicines Agency. SYSNAV Healthcare is now building the next generation of digital health technologies so patients benefit earlier and more reliably from life-changing treatments. SYSNAV and Roche have signed a multi-year partnership for the development of novel digital endpoints for neuromuscular diseases and movement disorders using SYSNAV's proprietary sensor technology, and are jointly developing the next generation of wearable devices. For more information, visit: https://healthcare.sysnav.com.
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