Biophytis presented its phase 3 protocol in the treatment of sarcopenia
Biophytis presented its phase 3 protocol aimed at demonstrating the potential of Ruvembri™ (20-hydroxyecdysone) in the treatment of sarcopenia at the International Conference on Frailty and Sarcopenia Research (ICFSR), held from March 20 to 22, 2024 in Albuquerque, NM, USA.
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. This outcome was replicated in pre-defined sub-populations at higher risk of mobility disability. 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 Ruvembri™ in the treatment of sarcopenic patients at risk of functional decline and disability. After receiving approval to initiate the study in Belgium and the United States, our drug candidate appears to be the most advanced in this indication and we are actively searching for pharmaceutical partners to develop it and finance its market access.”