Source – Sysnav Healthcare
The European Medicines Agency (EMA) has granted approval for the utilization of a digital measurement employing wearables, developed by Sysnav Healthcare, as a primary endpoint in clinical trials involving individuals with Duchenne muscular dystrophy (DMD). This landmark decision by a regulatory authority marks a significant advancement.
The endorsed measure, known as Stride Velocity 95th centile (SV95C), has been deemed suitable as an alternative to the widely utilized six-minute walking test (6MWT) in pivotal DMD trials encompassing patients aged four and above.
This latest endorsement builds upon SV95C’s earlier qualification by the EMA in 2019 as a secondary endpoint in DMD trials. However, the distinction now lies in its potential to serve as the primary outcome measure, a pivotal role in evaluating new therapies for DMD, instead of merely providing ancillary support.
This achievement is the culmination of 14 years of collaborative efforts involving a consortium of partners, including technology developers, academia, the pharmaceutical industry, caregivers, and notably, patients and families living with DMD.
The standard six-minute walking test (6MWT) is commonly regarded as a benchmark for assessing physical activity in DMD. However, infrequent and physically demanding in-clinic evaluations fail to capture real-world ambulation, particularly in situations relevant to patients’ daily activities affecting their quality of life.
“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. 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.
– Damien Eggenspieler, SYSNAV Healthcare program director
SV95C introduces the potential to decrease the required trial sample size, alleviate patient burden, and accurately capture real-world ambulation within contexts that hold significance for patients. This objective, real-world digital measure gauges peak performance by tracking the fastest strides over a recording span of 180 hours, utilizing Sysnav’s ActiMyo and Syde wearable devices. These devices track movement without relying on GPS positioning, thereby safeguarding patient privacy.
