Biophytis has achieved a significant regulatory milestone by receiving positive opinion from Belgian authorities to conduct SARA-31, the first phase 3 clinical trial ever launched for sarcopenia treatment. The biotechnology company also submitted applications to both the European Medicines Agency (EMA) and is preparing FDA submissions for this groundbreaking study of Sarconeos (BIO101).
The SARA-31 phase 3 study represents a major advancement in addressing sarcopenia, an age-related neuromuscular disease characterized by progressive loss of muscle strength and walking ability in elderly patients. According to Biophytis, this debilitating geriatric condition affects more than 30 million patients worldwide, yet no drug is currently approved anywhere in the world for its treatment.
Study Design and Patient Population
The SARA-31 trial will evaluate the efficacy and safety of Sarconeos (BIO101) in treating sarcopenic patients at risk of mobility disability. The study will enroll approximately 900 patients over 65 years of age with severe sarcopenia, defined by specific clinical criteria including Short Physical Performance Battery (SPPB) scores between 3 and 7, low walking speed (4-meter gait speed ≤ 0.8 m/s), and reduced grip strength (handgrip strength < 20kg for women and < 35.5 kg for men).
Participants will receive treatment for a minimum of 12 months and maximum of 36 months, with patients randomized to receive either placebo or 350mg of Sarconeos (BIO101) twice daily. The primary endpoint focuses on assessing the risk of Major Mobility Disability (MMD), measured by patients' ability to walk 400 meters in less than 15 minutes over time.
Secondary Endpoints and Clinical Leadership
Beyond the primary mobility assessment, the study will evaluate several secondary endpoints including walking speed using the 4-meter walking speed test from the SPPB, handgrip strength measurements, and patient-reported quality of life using the SarQol questionnaire, which was developed specifically for sarcopenia patients.
Roger A. Fielding, PhD, who heads the Nutrition, Physiology, Exercise and Sarcopenia (NEPS) laboratory at Tufts University in Boston, will serve as the principal investigator, continuing his contribution to the clinical development plan of Sarconeos (BIO101).
Regulatory Progress and Timeline
The positive opinion from Belgian authorities follows the company's submission of Clinical Trial Authorization (CTA) applications through the European portal of the EMA. Final authorization in Belgium depends on receiving a positive opinion from the Ethics Committee. Biophytis expects to initiate the study in Belgium in the coming quarter, pending final approvals.
The company has also filed a similar application with the FDA to conduct the study in the United States, with a response expected in the coming weeks. Additional authorizations may be requested in other countries based on study requirements.
Clinical Development Foundation
The launch of the Phase 3 program builds on encouraging results from the SARA-INT Phase 2b study and scientific advice provided by the EMA in 2022, which helped define the conditions for initiating phase 3 studies in sarcopenia and specified the protocol requirements.
Stanislas Veillet, CEO of Biophytis, emphasized the significance of this regulatory milestone: "Sarcopenia has only recently been recognised as a diagnosable disease, with no effective treatment option, despite the enormous medical need. We are pioneers in this field and intend to continue to establish our leadership by being the first company to launch, in partnership with global or regional pharmaceutical companies, a Phase 3 clinical development program in this indication."
The regulatory approval represents a critical step toward addressing the substantial unmet medical need in sarcopenia, a condition that leads to loss of autonomy and reduced life expectancy in elderly patients worldwide.
