(Boursier.com) — Biophytis SA, a clinical-stage biotechnology company specializing in the development of treatments that aim to slow the degenerative processes associated with aging and improve the functional outcomes of patients suffering from age-related diseases, including respiratory failure in patients suffering from COVID-19, announces today that it has submitted the application for authorization on the FDA (Food and Drug Administration) portal to launch its SARA-31 program in the United States , the very first phase 3 study in sarcopenia.
The launch of the Phase 3 program follows the promising results obtained during the SARA-INT phase 2b study and discussions with health authorities in 2022. Based on the results of the previous study and feedback from the he US government agency, Biophytis is starting its phase 3 program by filing the first phase 3 (SARA-31) authorization request in sarcopenia with the FDA. This application follows the one recently filed in Europe with the EMA (European Medicines Agency).
The objective of phase 3 is to assess the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of motor disability. Approximately 900 patients over the age of 65 with severe sarcopenia with low walking speed and low grip strength will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either the placebo or 350mg of Sarconeos (BIO101) twice a day. The main criterion will be the assessment of the risk of major motor disability (MMD, Major Mobility Disability), measured by the ability to walk 400m in less than 15 minutes.
In addition to this primary endpoint, the following secondary endpoints will be added: gait speed (walking speed over 4m from the SPPB – Short Physical Performance Battery test), grip strength (HGS) and result on quality of life declared by the patient. (Patient Reported Outcome SarQol, specific questionnaire developed for sarcopenia).
Biophytis expects a response from regulatory authorities during the third quarter of 2023, which would allow Biophytis to initiate the study in the United States. The principal investigator will be Roger A. Fielding, PhD, who directs the Nutrition, Physiology, Exercise and Sarcopenia (NEPS) Laboratory at Tufts University in Boston.
For Stanislas Veillet, Chairman and CEO of Biophytis: “After the success of phase 2b of SARA-INT, the filing of the authorization file with the EMA in mid-May and with the FDA today for the launch of “Phase 3 in sarcopenia marks a key milestone in the development of our drug candidate. We are pioneers in the sarcopenia field and intend to be the first company to launch, in partnership with global pharmaceutical companies or regional, a phase 3 clinical development program in this indication.”
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