Biophytis, a clinical-stage biotechnology company, has submitted an application for authorization with the FDA to initiate the SARA-31 Phase 3 study in sarcopenia. The purpose of this study is to assess the effectiveness and safety of Sarconeos (BIO101) in treating sarcopenic patients who are at risk of mobility disability. The company anticipates receiving a response from regulatory authorities in the third quarter of 2023.
Sarcopenia is a condition associated with aging that is characterized by the loss of muscle mass and strength, resulting in difficulties with mobility and an increased susceptibility to falls and fractures. It affects a significant number of older individuals worldwide and currently lacks approved treatment options.
The SARA-31 Phase 3 study will enroll approximately 900 participants aged 65 or older who have severe sarcopenia. These individuals will receive either placebo or Sarconeos twice daily for a minimum of 12 months and a maximum of 36 months.