Biophytis obtains FDA Authorization to initiate the SARA-31 phase 3 study in sarcopenia
This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study.
- This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study.
- The company still needs to obtain authorizations from ethics committees in the countries before launching this study.
- The effective start of the study is scheduled for 2024, and will depend on the conclusion of partnership agreements and the Company's financial resources.
- Stanislas Veillet, Chief Executive Officer of Biophytis, commented: "FDA approval suggests authorities may be increasingly aware of the growing need for effective therapeutics against a major disease in an aging society.