Biophytis presented its phase 3 protocol in the treatment of sarcopenia
The SARA-INT phase 2 study showed promising results on physical performance, with significant improvement in the 400 Meter Walking Test, reaching 0.07 m/s in the Full Analysis Set population and 0.09 m/s in the Per Protocol population.
- The SARA-INT phase 2 study showed promising results on physical performance, with significant improvement in the 400 Meter Walking Test, reaching 0.07 m/s in the Full Analysis Set population and 0.09 m/s in the Per Protocol population.
- Based on outcome of the SARA-INT phase 2 study and on results from the SPRINTT and LIFE studies, Biophytis designed an interventional, randomized, double-blind, placebo-controlled clinical phase 3 study (the SARA-31 study), expected to include 932 subjects.
- The poster presented at the ICFSR conference, which details the objectives and the design of the study, can be viewed by clicking on this link .
- Stanislas Veillet, CEO of Biophytis, stated: "The SARA-31 phase 3 study will assess the efficacy and safety of RuvembriTM in the treatment of sarcopenic patients at risk of functional decline and disability.