- Biophytis SA BPTS has announced top-line results of the SARA-INT phase 2 clinical study with Sarconeos (BIO101) in sarcopenia patients.
- Sarcopenia is a condition characterized by loss of skeletal muscle mass and function.
- The trial tested two doses of Sarconeos (BIO101), 175 mg bid and 350 mg bid, compared to placebo on gait speed measured by the 400-Meter Walk Test (400 MWT), the primary endpoint of the study.
- The highest dose of 350 mg bid showed a clinically meaningful improvement compared to placebo in gait speed after six months of treatment, of 0.09 m/s in the Full Analysis Dataset (FAS) population and 0.10 m/s Per-Protocol (PP) population.
- The 350 mg bid was associated with a reduction in mobility disability and mortality in the elderly.
- The 175 mg bid did not show a clinically meaningful difference compared to placebo in gait in both the population groups.
- No treatment effect was detected on the handgrip strength test and the PF10 sub-score of the SF-36 PRO on mobility disability, key secondary endpoints of the study.
- Sarconeos showed a favorable safety profile after up to 9 months of dosing, with no significant difference between treatments arms and placebo for Adverse Events, Serious Adverse Events, safety laboratory parameters, and vital signs.
- Adverse Events (AEs) percentages - were 36%, 37%, and 27% of the AEs for the placebo, 175 mg bid, 350 mg bid treatments, respectively.
- Serious AEs percentages - were 45%, 42% and 12% for placebo, 175 mg bid, 350 mg bid respectively.
- None of the Serious AEs were related to the treatment.
- Price Action: BPTS shares traded higher by 28% at $10.99 in premarket trading on the last check Monday.
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