Biophytis Advances Ruvembri to Phase 3 Trial for Sarcopenia Treatment Following Promising Phase 2 Results
Key Insights
Biophytis presented its SARA-31 phase 3 protocol for Ruvembri (20-hydroxyecdysone) in sarcopenia (search) treatment at the International Conference on Frailty and Sarcopenia Research.
The preceding SARA-INT phase 2 study demonstrated significant improvements in physical performance, with 0.07 m/s improvement in the 400 Meter Walking Test in the Full Analysis Set population.
The randomized, double-blind, placebo-controlled phase 3 study will include 932 subjects and has received regulatory approval to begin in Belgium and the United States.
Biophytis SA has unveiled its phase 3 clinical trial protocol for Ruvembri (20-hydroxyecdysone) in the treatment of sarcopenia (search), positioning the biotechnology company's lead drug candidate as potentially the most advanced therapeutic in this indication. The company presented the SARA-31 study design at the International Conference on Frailty and Sarcopenia Research held March 20-22, 2024 in Albuquerque, New Mexico.
Phase 2 Results Drive Phase 3 Design
The advancement to phase 3 follows encouraging results from the SARA-INT phase 2 study, which demonstrated significant improvements in physical performance among sarcopenic patients. The study showed a 0.07 m/s improvement in the 400 Meter Walking Test in the Full Analysis Set population and a 0.09 m/s improvement in the Per Protocol population. These positive outcomes were consistently replicated across pre-defined sub-populations at higher risk of mobility disability.
The SARA-31 phase 3 study represents an interventional, randomized, double-blind, placebo-controlled clinical trial designed to include 932 subjects. Biophytis developed the study protocol based on outcomes from the SARA-INT phase 2 study and results from the SPRINTT and LIFE studies.
Regulatory Approval and Market Position
The company has secured regulatory approval to initiate the phase 3 study in both Belgium and the United States. According to CEO Stanislas Veillet, "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."
Partnership Strategy
Biophytis is actively pursuing pharmaceutical partnerships to support the development and financing of Ruvembri's market access. Veillet emphasized the company's strategic focus on finding partners to advance the drug candidate through the final stages of clinical development.
About Ruvembri and Biophytis
Ruvembri, a small molecule based on 20-hydroxyecdysone, represents Biophytis's lead drug candidate in development for age-related neuromuscular diseases including sarcopenia (search) and Duchenne muscular dystrophy (search), as well as cardiorespiratory conditions such as COVID-19 (search). The clinical-stage biotechnology company specializes in developing therapeutics aimed at slowing degenerative processes associated with aging and improving functional outcomes for patients with age-related diseases.
The company maintains operations in Paris, France, and Cambridge, Massachusetts, with ordinary shares listed on Euronext Growth and American Depositary Shares traded on Nasdaq Capital Market.