(News Bulletin 247) – Biophytis announces today that it has submitted the authorization application file on the European portal of the European Medicines Agency (EMA) to launch SARA-31, the first phase 3 study in sarcopenia.
The objective of the SARA-31 phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos in the treatment of sarcopenic patients at risk of motor disability.
The main criterion will be the assessment of the risk of major motor disability measured by the ability to walk 400m in less than 15 minutes over time.
Biophytis expects a response from the regulatory authorities during the next quarter, which would allow Biophytis to initiate the study in Belgium.
In addition, Biophytis is currently working on the preparation of the documents to be submitted to the FDA in order to request authorizations to start the phase 3 study also in the United States.
For Stanislas Veillet, CEO of Biophytis: ‘No drug is currently approved in the world for sarcopenia. We are pioneers in this field and intend to continue to establish our leadership by being the first company to launch a phase 3 clinical development program in this indication.’
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