SARA-INT PHASE 2B INTERVENTIONAL CLINICAL TRIAL
We are currently testing the safety and efficacy of Sarconeos (BIO101) in a global, randomized,multicenter, double-blind, placebo-controlled Phase 2b clinical trial (SARA-INT) in sarcopenia. In February 2020, the FDA (USA) and AFMPS (Belgium), approved a protocol amendment reducing by 30% the number of patients to be recruited into the SARA-INT clinical trial from 334 to 231 patients.
This reduction in patient numbers does not change the objectives, endpoints or statistical power of the SARA-INT clinical trial, and allows Biophytis to expect completion of patient recruitment in Q2 2020.
- Evaluate the safety and effectiveness of two doses, 175 and 350 mg b.i.d. (twice daily) of Sarconeos (BIO101) administered orally with a meal for 26 weeks against a placebo in participants over 65 at risk of impaired mobility.
- Measure treatment effect on improvement of physical function and on decrease of risk of mobility disability after six-month treatment.
- Based on a Short Performance Physical Battery (SPPB) score ≤ 8 out of 12 (as an index of loss of motor function) and the Foundation for the National Institutes of Health (FNIH) guidelines.
- Change from baseline in the time it takes to complete the 400-meter walk test (400MWT). A minimum clinically significant benefit is set at 0.05 meters per second (m/s) in the mean difference between groups.
Key Secondary Endpoints
- Change from baseline in the time it takes to rise from a chair (a component of the SPPB test).
- 400MWT responder analysis.
- Change from baseline and responder analysis on standard patient reported outcome (PRO), including the Short-form Health-survey (SF-36), and the Physical Function domain (PF-10) of the SF-36 questionnaire.
Pre-defined Subgroup Analysis
- A “very low walking speed subpopulation” defined as having a gait speed ≤ 8 m/s in the 4-meter walk test (a component of the SPPB test).
- A “subpopulation with sarcopenic obesity” defined by a body fat percentage of >25% for men and >35% for women.
- A population pharmacokinetic (PK) sub-study (SARA-POP-PK) will evaluate PK values after one month, three months and six months of administration in a subgroup of participants at certain European centers.
For more information please visit clinicaltrials.gov (Identifier: NCT03452488).
SARA-OBS PHASE 2 OBSERVATIONAL STUDY
Beginning in February 2017, the SARA-OBS observational study followed 218 participants with sarcopenia across 11 clinical centers in the United States and Europe (France, Italy and Belgium) over six months. We completed the study with last patient out in April 2019 .
The objective of the SARA-OBS study was to characterize sarcopenia in patients over the age of 65 at risk of mobility disability by evaluating the mobility and physical performance, including body composition, of these participants. SARA-OBS was designed and structured as a pre-selection for the SARA-INT Phase 2b clinical trial, and participants in SARA-OBS may be eligible to enroll in the SARA-INT Phase 2b clinical trial at the end of the observation period following a rescreening and reconsenting process.
SARA-PK PHASE 1 CLINICAL TRIAL
In 2017, we presented results from a dose-escalating Phase 1 clinical trial (SARA-PK) that evaluated the safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of Sarconeos (BIO101) in 54 healthy adult and elderly volunteers. The SARA-PK trial allowed us to determine the two safe, active dosing levels (175 and 350 mg b.i.d.) for our ongoing SARA-INT Phase 2b clinical trial.