Biophytis Receives Positive Evaluation for Phase 3 SARA-31 Trial Addressing Sarcopenia in Europe
Tuesday, August 08, 2023
Biophytis SA, a biotechnology company listed on Nasdaq CM (BPTS) and Euronext Growth Paris (ALBPS), has received favorable feedback from Belgian authorities to initiate the innovative SARA-31 initiative. The company specializes in developing treatments targeting age-related degenerative processes, with a focus on improving the health of individuals afflicted by age-related ailments. This encompasses addressing severe respiratory complications in COVID-19 patients. This recent announcement marks a significant stride, as the company plans to commence the very first Phase 3 clinical trial for sarcopenia.
The decision to progress to Phase 3 follows encouraging outcomes from the SARA-INT Phase 2b study and guidance provided by the European Medicine Agency (EMA) in 2022. The EMA's guidance helped shape the Phase 3 protocol, with final authorization pending approval from the Ethics Committee in Belgium. A parallel application has been submitted to the Food and Drug Administration (FDA) to conduct the study in the United States, and a response is anticipated in the coming weeks. Further approvals may be sought in other countries as necessary.
Stanislas Veillet, the CEO of Biophytis, emphasized the significance of this achievement. He highlighted the urgency of addressing sarcopenia, a condition characterized by gradual muscle weakness and diminished mobility in older adults. Despite the substantial global need, there are currently no approved drugs for this condition. The positive regulatory feedback marks a notable step towards conducting a Phase 3 clinical trial in this realm, which affects more than 30 million patients worldwide.
The Phase 3 program, named SARA-31, aims to evaluate the efficacy and safety of Sarconeos (BIO101) in treating individuals with severe sarcopenia at risk of motor disability. The trial intends to enroll around 900 participants aged over 65, meeting specific criteria for low walking speed and grip strength. Participants will be assigned to receive either a placebo or a daily dose of 350mg Sarconeos (BIO101) for a duration spanning 12 to 36 months. The primary focus will be on assessing the risk of Major Mobility Disability (MMD), gauged by the ability to walk 400 meters in less than 15 minutes. Secondary criteria encompass metrics such as walking speed, grip strength, and patient-reported quality of life.
Leading the SARA-31 study is Roger A. Fielding, PhD, an authority in sarcopenia and the director of a laboratory at Tufts University in Boston. His involvement underscores the commitment to advancing the clinical development of Sarconeos (BIO101) for this specific indication.
