A Paese 2b interventional trial
SARA-INT was the first Phase 2b trial of BIO101 (Sarconeos) in sarcopenia — a randomised, double-blind, placebo-controlled study run across the European Union and the United States, in community-dwelling adults aged 65 and over at risk of mobility disability. Sponsored by Biophytis, it tested whether the drug candidate could improve walking speed and physical function over six months, compared with placebo. The study completed successfully, and Biophytis reported positive top-line results on the primary endpoint — the 400-metre walk test — with a good safety profile.