Biophytis Showcases Phase 3 Sarcopenia Treatment Protocol

Biophytis SA, a clinical-stage biotechnology firm, has unveiled its phase 3 protocol for RuvembriTM, a drug candidate developed to combat sarcopenia, at the International Conference on Frailty and Sarcopenia Research. The company is focused on creating therapeutics that mitigate the effects of aging and enhance the functionality of those with age-related diseases. The phase 2 SARA-INT study demonstrated significant progress in physical performance, particularly in the 400 Meter Walking Test, with improvements of 0.07 m/s in the Full Analysis Set population and 0.09 m/s in the Per Protocol population. These results were consistent in sub-populations at a higher risk of mobility issues.

Following the phase 2 study's success and additional data from the SPRINTT and LIFE studies, Biophytis has initiated a phase 3 study, the SARA-31 study, which is designed to be a randomized, double-blind, placebo-controlled clinical trial involving 932 participants. The study's objectives and design were detailed in a poster at the conference.

Stanislas Veillet, CEO of Biophytis, highlighted the importance of the SARA-31 study, which will evaluate the effectiveness and safety of RuvembriTM for sarcopenic patients at risk of functional decline and disability. The company has received approval to begin the study in Belgium and the United States and is actively seeking pharmaceutical partners to aid in development and market access.

Biophytis SA is dedicated to developing drug candidates for diseases associated with aging, with RuvembriTM as its lead candidate. The molecule is being developed for age-related neuromuscular and cardiorespiratory diseases, showing promise in international phase 2 studies for sarcopenia and in phase 2-3 trials for severe COVID-19. Additionally, a pediatric formulation is in development for Duchenne Muscular Dystrophy treatment. The company operates from Paris, France, and Cambridge, Massachusetts, with shares listed on both Euronext Growth and Nasdaq Capital Market.