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 well as for COVID-19 and Duchenne muscular dystrophy (DMD).
Sarconeos (BIO101) for Obesity
Obesity is highly prevalent in the United States and globally, and Biophysis is one of several companies seeking to advance its candidates by complementing the highly successful GLP-1 receptor agonist class of weight loss drugs. These drugs are highly effective at inducing weight loss, but, as with other weight-loss methods, subjects tend to lose approximately one-quarter of their weight as lean mass rather than adipose tissue. BIO101 could potentially allow subjects to retain more muscle and have more favorable metabolic and functional outcomes.
Additionally, 96% of obese people report limitations on their mobility and are at risk of sarcopenic obesity (SO), a condition characterized by the loss of muscle mass and function alongside an excess of adipose tissue. SO is thus especially disabling as well as metabolically unhealthy, and BIO101 could potentially prove highly useful in this population.
Biophysis has stated that in diet-induced obese mice, four weeks of concomitant treatment with BIO101 and a GLP-1 receptor agonist improves mobility and grip strength relative to untreated groups, and that the “combination of drugs compensates for muscle contractility alterations.”
At the 15th International Conference on Frailty and Sarcopenia in Toulouse, Biophytis-affiliated scientists reported that BIO101 promoted the differentiation of mouse and human myocytes, and that it “improved muscle function and physical capacity” in an unspecified model. In mice made obese through feeding a high-fat diet, BIO101 reduced the accumulation of adipose tissue by limiting the increase in adipocyte size, and also inhibited the rise in adipokines, inflammatory markers, and osteopontin (a regulator of obesity-driven inflammation and insulin resistance), and inhibited the expression of lipoprotein lipase (which is important for fat storage in times when insulin levels are high).
In 2017, Biophytis launched SARA-OBS (NCT03021798), an observational study in sarcopenic obesity (SO) that it characterized as a “single-arm phase 2 clinical trial, with no investigational product and no therapeutic intervention that will be conducted in three European countries … and in the US.”
In March 2020, Biophytis announced that company management would make a presentation on the preliminary baseline characteristics and changes from baseline in the first group of patients in the SARA-OBS observational study. The study was completed on June 30, 2020. In the 2025 publication of the results, Biophytis researchers stated that the purpose of the study was “to better characterize sarcopenia (including SO) and its consequences on physical function over time, in community-dwelling older adults at risk of mobility disability, and to support the design of further interventional clinical trials.” The study assessed the change over 6 months in the 400-meter walking test (400MWT), grip strength, 6-minute Walking Distance (6MWD), and domains of the Short Physical Performance Battery (SPPB).
In July 2024, Biophytis announced that FDA had granted its Investigational New Drug (IND) application for its Phase II OBA clinical trial of BIO101 in obesity. The primary endpoint was to be the knee extension test, with secondary endpoints to include the 6-minute walk test (6MWT) and body composition (adipose and lean mass). The company advised that the trial would begin in mid-2024 in the United States and “could be extended to Europe.”
The company also highlighted that the principal investigator would be Marc-André Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina and President of the American Obesity Society (now the Obesity Society).
In March 2025, at the 15th International Conference on Frailty and Sarcopenia in Toulouse, Biophytis-affiliated scientists reported clinical trial results with BIO101 in overweight or obese subjects: it is not clear to us whether this is an unannounced early trial or a subgroup analysis of their Phase II trial in sarcopenia, though the latter does not seem likely, as a weight loss phase is mentioned.
In any event, the researchers reported that BIO101 significantly decreased android (central) adipose tissue mass in these subjects, and that the diameter of their biopsied adipocytes was significantly reduced. There was also a trend toward increased grip strength among subjects who lost more than 5% of their initial weight during the weight loss phase. The researchers also outlined the design of OBA, a randomized, double-blind, placebo-controlled Phase II trial of BIO101 in subjects using semaglutide for obesity or overweight (BMI≥27) with at least one obesity-driven metabolic derangement. The endpoints in the protocol outline are in line with Biophytis’ announcement when they received their IND, and the Conference abstract states that the regulators had approved the combination of BIO101 with a GLP-1 RA, and that the trial would soon be initiated, subject to ongoing discussions with ethics committees, possible protocol amendations, and expansion to other jurisdictions.
The launch of the trial was affirmed again in a press announcement the following month (April 2025), which however quoted COE Veillet as saying, “The company’s priority is now to find a pharmaceutical partner to co-develop BIO101 in obesity. This partner will support us in the clinical and regulatory development of our drug candidate through to marketing authorization and will lead the product launch in North America.”
