Transitioning from SARA-OBS, an observational study to SARA-INT, a double-blind, placebo controlled, randomized clinical trial to evaluate safety and efficacy of Sarconeos (BIO101)

INTRODUCTION: Sarcopenia, is characterized by the loss of muscle mass and muscle strength leading to a global muscle functional impairment and physical disability. SARA‐OBS, is the ongoing observational study dedicated to characterized the population for SARA‐INT, the interventional study with the investigational drug BIO101. Both studies are hosted in SARA‐Data, an innovative platform for clinical trials. METHODS: SARA‐OBS study consists of two main visits (baseline and 6‐month) to evaluate the main (400‐meter gait speed), and secondary endpoints (6‐minute walk, body composition, SPPB, grip strength and physical activity through actimetry). Patient Reported Outcomes and biomarkers of sarcopenia are also studied. Patients in SARA‐OBS study are recruited within centers in US and EU (France, Belgium and Italy), based on the FNIH criteria (Studenski et al..., 2014; ALM/BMI < 0.512 in women and < 0.789 in men or ALM <19.75 kg in men and < 15.02 kg in women) as well as SPPB ≤8. SARA‐INT shares the same inclusion criteria, will take place in 21 sites in EU and US and will consist of four main visits (baseline, Month1, Month3, and Month6). Newly recruited patients and patients retained from SARA‐OBS will be dosed at BIO101–175 mg b.i.d. and 350 mg b.i.d during 26 weeks versus placebo. The main end‐point is the gait speed at the 400‐meter walking test) as for SARA‐OBS. RESULTS: SARA‐OBS recruitment rates will be discussed including main screening failure reasons. Baseline characteristics including main (400 m gait speed) and key secondary criteria will be presented. Analysis of a first set of patients that have completed the investigational phase (ie 6 month visit) will be discussed. Baseline characteristics of the first randomized patients within the SARA‐INT study will be presented. CONCLUSIONS: The SARA‐OBS study contributed to a better characterization of Age‐related Sarcopenia patients that will transition to SARA‐INT to evaluate safety and efficacy of BIO101.