Biophytis seeks US FDA approval to initiate SARA-31 phase 3 study in sarcopenia
Biophytis SA, a clinical-stage biotechnology company, announced that it has filed for approval on the Food and Drug Administration (FDA) portal to launch its SARA-31 programme in the US, the first ever phase 3 study in sarcopenia.
The launch of the phase 3 programme follows promising results from 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 US government agency, Biophytis is starting its phase 3 program by filing the first ever phase 3 application (SARA-31) in sarcopenia with the FDA. This follows the recent submission to the European Medicines Agency.
Biophytis expects a response from the regulatory authorities during the third quarter of 2023, which would enable Biophytis to initiate the study in the United States. The principal investigator will be Roger A. Fielding, PhD, who heads the Nutrition, Physiology, Exercise and Sarcopenia (NEPS) Laboratory at Tufts University in Boston.
Stanislas Veillet, chairman and CEO of Biophytis stated: “Following the success of SARA-INT’s phase 2b clinical trial, the filing of an application with the EMA in mid-May and with the FDA today for the launch of a phase 3 clinical trial in sarcopenia is a major milestone in the development of our drug candidate. We are pioneers in the field of sarcopenia and intend to be the first company to launch, in partnership with global or regional pharmaceutical companies, a phase 3 clinical development program in this indication.”