Biophytis has enrolled and treated the first patient in its SARA-INT trial, a Phase IIb clinical study of Sarconeos for treatment of sarcopenia.
As part of the double-blind, placebo-controlled trial, approximately 334 patients will be enrolled in 22 clinical centres in Belgium, France, Italy and the US.
The trial will include nearly half of its patients from an observational study, SARA-OBS, which has been conducted by Biophytis at some of the key clinical centres over the past year.
Remaining patients will be enrolled from 11 new clinical centres, which are in the process of opening.
With patient enrolment due for completion by the year-end, the trial plans to release preliminary and final results next year.
The study seeks to examine the safety and efficacy of two doses of BIO101 that will be administered orally for 26 weeks against placebo in a population of men and women aged 65 years and older.
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It also aims to determine the effect of treatment, improvement of physical function, and decreased risk of motor disability after six months of treatment with placebo.
In addition, the study’s main evaluation criteria includes walking speed measured during a 400m test.
Its main secondary endpoints are the variation from baseline of standard patient-reported outcome (PRO): PF-10 score of SF36; chair-lift test (SPPB intermediate score).
Other secondary evaluation criteria of the trial are the change in baseline of appendix body mass (ALM), body composition measured by DEXA, muscle strength (handle / knee extension); climb test of the stairs; SPPB; six-minute walk.