Monday, July 10, 2023
Biophytis SA, a clinical-stage biotechnology company, has submitted an application to the Food and Drug Administration (FDA) to initiate its SARA-31 program in the United States. This program represents the first-ever Phase 3 study in sarcopenia, a condition associated with muscle loss and weakness in aging patients.
The decision to move forward with the Phase 3 program is based on promising results from the SARA-INT Phase 2b study and discussions with health authorities in 2022. Biophytis has also submitted an application to the European Medicines Agency. The objective of the SARA-31 Phase 3 study is to evaluate the efficacy and safety of Sarconeos (BIO101) in treating sarcopenic patients at risk of mobility disability.
The study aims to enroll approximately 900 patients over the age of 65 with severe sarcopenia and low physical function. Participants will be treated for a period of 12 to 36 months, receiving either a placebo or a 350mg dose of Sarconeos twice daily. The primary endpoint of the study is to assess the risk of Major Mobility Disability (MMD), measured by the ability to walk 400 meters in less than 15 minutes. Secondary endpoints include walking speed, handgrip strength, and patient-reported quality of life.
Biophytis expects to receive a response from regulatory authorities in the third quarter of 2023, which would allow them to initiate the study in the United States. The principal investigator for the trial will be Roger A. Fielding, PhD, from Tufts University in Boston.
Stanislas Veillet, Chairman and CEO of Biophytis, expressed his excitement about the progress made in the development of their drug candidate. He emphasized their commitment to pioneering advancements in sarcopenia treatment and their intention to collaborate with global or regional pharmaceutical companies to launch the phase 3 clinical development program in this area.
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