Biophytis‘ longevity platform page delineates the Hallmarks of Aging, but goes on to say “We explore and identify the fundamental mechanisms of aging by targeting pathways like Mas-related G protein-coupled receptor (MasR), which is part of the renin angiotensin system [RAS], Peroxisome proliferator-activated receptor pathway and key inflammatory and angiogenic signaling routes, including NF-κB and AP-1 transcription factors.”
Biophytis’ most advanced candidate, BIO101, and possibly Biophytis itself originated with SARCOB, a consortium of French companies and academic laboratories formed to develop drug and dietary supplement candidates for sarcopenic obesity. Members of the consortium tested various candidates in murine and human muscle cell lines as well as myocye-adipocyte co-cultures and in different rodent models, and the receptor for phytoecdysteroids in muscle was identified.
From this emerged Biophytis’ most advanced candidate: 20-hydroxyecdysone, a phytoecdysteroid that plays a key role in insect development and activates the MAS receptor in mammals. The MAS receptor is a node in the protective alternative RAS pathway that counteracts the effects of the classical RAS pathway centered on AT1R. MasR’s principal ligand is Ang 1-7, a bioactive metabolite produced by ACE2. Under the name BIO101 (also known as Sarconeos or Ruvembri for some indications and time periods), Biophytis is developing 20-hydroxyecdysone for indications related to sarcopenia and obesity, as well as for COVID-19 and Duchenne muscular dystrophy (DMD).
BIO101 (AKA Sarconeos and Ruvembri) for Sarcopenia
In April 2022, Biophytis-affiliated scientists presented the results of the Phase II SARA-INT trial of BIO101 for sarcopenia (NCT03452488). 233 participants were randomized into one of three arms: 175 mg BIO101 twice daily, 350 mg twice daily, or placebo. For most subjects, the trial lasted 6 months, but for 50 subjects it was extended to a total of 9 months. The primary endpoint was the 400-meter walking test (400MWT), with additional physical activity assessments as secondary endpoints.
BIO101 failed in the primary analysis, perhaps in part because approximately half of the subjects’ final assessments were missing due to the COVID pandemic, thereby lowering the trial’s statistical power. There was a nonsignificant trend toward an improvement of 0.07 m/s in the 400MWT of the 350 mg twice daily group at 6 months, and a nominally significant improvement of 0.09 m/s in this group in the per-protocol population (p=0.008); the investigators noted that this result, if not an artifact, approaches the Minimal Clinically Important Difference (MCID) in sarcopenia of 0.1 m/s. This result also held in predefined high-risk subpopulations, and the abstract stated that the investigators had observed trends in unspecified additional endpoints and subgroups.
In May 2023, Biophytis announced that it had submitted an application to the European Medicines Agency (EMA) for Clinical Trial Authorization (CTA) to launch the Phase III SARA-31 trial, the first Phase III trial in sarcopenia. In September 2023, Biophytis announced that FDA had granted it approval to initiate the SARA-31 trial in the US.
Similar to SARA-INT, SARA-31 will evaluate BIO101 in approximately 900 people over the age of 65 years with severe sarcopenia who are at risk of mobility disability. Treatment will continue for at least a year and up to three. The primary endpoint will be a version of the 400MWT, with secondary endpoints including the 4 minute walking speed from the Short Physical Performance Battery (SPPB) test, grip strength, and patient-reported quality of life (on the sarcopenia-specific Patient Reported Outcome SarQol questionnaire.
In March 2025, Biophytis announced the publication of SARA-INT. The full publication added some information on subgroup analyses and highlighted BIO101’s good safety profile.
In July 2025, Biophytis announced a strategic partnership with Lynx Analytics, a company working in artificial intelligence solutions for life sciences, “to accelerate the discovery and development of novel small molecule drugs for the treatment of sarcopenia”.
In October 2025, Biophytis announced that it had inked a Memorandum of Understanding (MoU) with a consortium of investors that included Ronghui Renhe Life Technology to finance and launch the SARA-31 trial. The company stated that it anticipates commencement early in 2026. Under the terms, the investors are to invest up to US$20 million over the following two years to fund the trial and have the right to develop and exclusively commercialize BIO101 in China, Japan, and Korea. Under the MoU, Biophytis will recruit up to 932 subjects with sarcopenia and will include subjects in Asia in addition to Europe.