Biophytis receives a positive opinion for its SARA-31 phase 3 study in sarcopenia in Europe
Biophytis announced that it has received a positive opinion from Belgian authorities to conduct its SARA-31 program, which will be the first phase 3 study ever launched in sarcopenia.
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. A similar application has been filed with the FDA (Food and Drug Administration) to start this study in the United States, with a response expected in the coming weeks. Further authorizations may be requested in other countries, depending on the needs of the study.
Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “This opinion is a major step forward in our efforts to treat sarcopenia, an age-related neuromuscular disease characterized by the progressive loss of muscle strength and walking in the elderly, leading to loss of autonomy and reduced life expectancy. Despite the enormous medical need posed by this disease, no drug is currently approved anywhere in the world. Today, we are putting our pioneering position in this field into practice by obtaining, for the first time, a positive opinion from a regulatory agency to conduct a phase 3 clinical trial in this debilitating geriatric disease, which affects more than 30 million patients worldwide”.