{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T05:11:27Z","timestamp":1792559487875,"version":"4.5.0"},"reference-count":40,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T00:00:00Z","timestamp":1740960000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T00:00:00Z","timestamp":1740960000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J cachexia sarcopenia muscle"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Sarcopenia is a progressive muscle disorder that may lead to mobility disability. No pharmaceutical interventions are currently available, and treatment relies on physical exercise and nutrition. The aim of SARA\u2010INT was to investigate whether BIO101 (20\u2010hydroxyecdysone), an activator of the MAS receptor, is safe and improves muscle function and physical performance of community dwelling older sarcopenic patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>SARA\u2010INT was a randomised three\u2010arm interventional study (BIO101 175\u2009mg bid \/350\u2009mg bid\/placebo) with a planned 6\u2010month treatment (up to 9\u2009months in 50 subjects). Eligibility criteria for sarcopenia were meeting FNIH criteria for sarcopenia and Short Physical Performance Battery (SPPB) score \u2264\u20098\/12 in men and women aged \u2265\u200965\u2009years. Primary endpoint was the change from baseline (CFB) in gait speed (GS) measured by 400\u2010m walking test (400MWT), secondary endpoints being CFB in other physical performance tests.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 233 participants were randomised (mean age 75.5\u2009\u00b1\u20097.12; 54.3% female), of whom 232 and 156 were included in the full analysis set (FAS) and per\u2010protocol (PP) populations, respectively. Due to COVID\u201019 pandemic, 55% of on\u2010site end\u2010of\u2010treatment efficacy assessments were lost, reducing the studies' power. In the primary analysis (mix of 6\/9\u2009months), BIO101 350\u2009mg bid treatment after 6\/9\u2009months was associated with an improvement in the 400MWT of 0.07\u2009m\/s versus placebo in the FAS population (not significant) and of 0.09\u2009m\/s in the PP population (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.008). BIO101 350\u2009mg bid treatment effect on the 400MWT GS was also observed in pre\u2010defined subpopulations at higher risk of mobility disability (0.0474\u2009m\/s for slow walkers, 0.0521\u2009m\/s for obese and 0.0662\u2009m\/s for chair stand sub\u2010score \u2264\u20092 from SPPB in the FAS population), with a trend for a dose response. BIO101 showed a good safety profile at both doses (number of subjects with related treatment emergent adverse events (TEAEs) of 13 (16.0%), 10 (13.3%) and 10 (13.5%) in the placebo, 175\u2009mg and 350\u2009mg BIO101 groups, respectively).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>After 6 to 9\u2009months of treatment, BIO101 350\u2009mg bid showed strong trends consistent with a clinically relevant effect on the 400MWT GS, close to the minimal clinically important difference (MCID) in sarcopenia (0.1\u2009m\/s). This was also shown in predefined subpopulations at higher risk of mobility disability. BIO101 showed a good safety profile. Taken together, efficacy and safety data of this Phase 2 trial encourage us to pursue further development of BIO101 for the treatment of sarcopenia.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcsm.13750","type":"journal-article","created":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T23:41:18Z","timestamp":1741736478000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["BIO101 in Sarcopenic Seniors at Risk of Mobility Disability: Results of a Double\u2010Blind Randomised Interventional Phase 2b Trial"],"prefix":"10.1002","volume":"16","author":[{"given":"Roger\u00a0A.","family":"Fielding","sequence":"first","affiliation":[{"name":"Nutrition, Exercise Physiology, and Sarcopenia Laboratory Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael\u00a0M.","family":"Dao","sequence":"additional","affiliation":[{"name":"AMD Medical Group and National Institute of Clinical Research Inc.  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