The first digital functional assessment tool validated in DMD

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The international consortium of researchers, including experts from the Institute of Myology, which developed SV95C, a digital parameter for the functional evaluation of Duchenne muscular dystrophy (DMD), has announced its adoption by the European Medicines Agency (EMA) as a primary endpoint in therapeutic trials:

  • this assessment is based on the analysis of information transmitted by sensors worn by DMD patients,
  • This technological innovation, developed by SYSNAV, enables non-invasive measurement of the patient’s movements and displacements,
  • SV95C corresponds to the 5% fastest movements of the day,
  • The EMA has authorized its use as a major evaluation criterion in future therapeutic trials, from the age of 4 upwards.

This is a first in the field of assessment tools for DMD.

 

Evidentiary basis of the first regulatory qualification of a digital primary efficacy endpoint. Servais L, Strijbos P, Poleur M, et al. Sci Rep. 2024 Nov.

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