Biophytis Stock Gains As Sarconeos High Dose Improves Gait Speed Versus Placebo In Patients With Muscle Loss Due To Aging
Biophytis SA (NASDAQ: 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.
See more from Benzinga
FDA Approves Regeneron - Roche's COVID-19 Antibody Cocktail For Post-Exposure Prophylaxis
Oncology-Focused Biotech Immuneering Jumps To Wall Street With 2M IPO
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.