SARCOPENIA: SARA CLINICAL PROGRAMME
1. An age-related disease with no drug treatment
Sarcopenia is a disease characterised by a progressive and widespread loss of skeletal muscle mass and function, leading to muscle weakness, and is related to falls, disability, a significant reduction in quality of life and death. Sarcopenia affects between 10% and 16% of people over 60, or more than 150 million people worldwide.
To date, no pharmacological treatment has been approved for sarcopenia. Recommendations for the prevention and treatment of this age-related muscular disease are mainly based on lifestyle interventions such as nutrition and physical exercise. However, none of these recommendations are fully effective in providing relief for patients, and no drug has yet been approved by health authorities.
2. Biophytis, the only biotech company able to start a phase 3 study in sarcopenia (depending on partnership)
BIO101 (20-hydroxyecdysone) is the first drug candidate to complete a Phase 2 trial (SARA-INT) with promising clinical results on mobility in elderly patients with sarcopenia. In this clinical study, our drug candidate demonstrated a significant improvement in walking speed based on the 400-meter walk test (400MWT), the study’s primary endpoint (per protocol analysis). These promising results on mobility were also demonstrated in the obese sarcopenic subpopulation, which is particularly at risk.
Biophytis is the only biotechnology and pharmaceutical company to have received authorisation from the EMA (European Medicine Agency) and the FDA to launch the first phase 3 study in sarcopenia, Biophytis’ SARA-31 programme, in Europe and the United States.
3. Biophytis is looking for partners to conduct a phase 3 programme in the upcoming months
BIO101 (20-hydroxyecdysone) has the potential to be the first drug to treat patients suffering from sarcopenia. The primary endpoint of this Phase 3 trial, as presented to the agencies, is the ability to complete the 400 m walk test in less than 15 minutes, where the proportion of patients unable to perform this, reaching mobility disability, is the primary efficacy variable. This primary endpoint will be supplemented by the secondary endpoints of hand grip strength and Patient Reported Outcomes.
The start of the phase 3 study will depend on the conclusion of agreements with pharmaceutical partners and the Company’s financial resources. Biophytis intends to launch this study as soon as possible.