FRANKREICH

Biophytis receives a positive opinion for its SARA-31 phase 3 study in sarcopenia in Europe

Retrieved on: 
Mardi, août 8, 2023

The launch of the Phase 3 program follows the promising results obtained in the SARA-INT Phase 2b study, and the scientific advice given in 2022 by the EMA (European Medicine Agency), which helped define the conditions for starting such a study in Europe, specifying the Phase 3 protocol.

Key Points: 
  • The launch of the Phase 3 program follows the promising results obtained in the SARA-INT Phase 2b study, and the scientific advice given in 2022 by the EMA (European Medicine Agency), which helped define the conditions for starting such a study in Europe, specifying the Phase 3 protocol.
  • Final authorization depends on a positive opinion from the Ethics Committee in Belgium.
  • Further authorizations may be requested in other countries, depending on the needs of the study.
  • Despite the enormous medical need posed by this disease, no drug is currently approved anywhere in the world.