Biophytis Presented its Phase 3 Protocol in the Treatment of Sarcopenia
Biophytis and Skyepharma, a French pharmaceutical company specializing in the formulation, development and production of pharmaceutical products, announce the signature of a partnership agreement for the production of regulatory batches of Sarconeos (BIO101) for severe forms of Covid-19, with a view to the submission of marketing authorization applications.
Biophytis announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries.
Stanislas Veillet, Chief Executive Officer of Biophytis, stated: “Over the past two years, Biophytis has made significant progress in the development of its key asset Sarconeos (BIO101). Our COVA programme in severe forms of COVID-19 has demonstrated its efficacy in a phase 2/3 study and we are currently discussing the next steps with the regulatory authorities, in particular the implementation of early access for patients in France and Brazil. Meanwhile, our SARA programme in sarcopenia has obtained authorization to start a phase 3 trial in the United States and Belgium. In this context, the arrival of Edouard Bieth as Chief Business Officer is a key element in accelerating the availability of our drug candidates. He will lead our market access and commercialisation strategy and will be responsible for establishing partnerships with a view to co-development and licensing agreements for our two key programmes. I am delighted to welcome him to the team, who will benefit from his experience and extensive knowledge of the pharma/biotech ecosystem.”