Biophytis is a clinical-stage biotechnology company focused on the development of transformative therapies for diseases of aging, particularly sarcopenia (the age-related loss of muscle mass and strength, even in people who perform resistance training) and its interface with obesity. Its CEO is Stanislas Veillet; its CSO is Pierre J. Dilda; its CMO is Samuel Agus, M.D.

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.” Elsewhere, they say they have “a unique platform that combines synergistic technology modalities systematically accelerated by AI through our partnership with Lynx Analytics. This enables us to discover therapeutic solutions across the aging disease spectrum.”

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.

The virus that causes COVID-19 uses the ACE2 receptor on the surfaces of epithelial and endothelial cells to infect them. It was therefore a common hypothesis early in the pandemic that agents that also bind to ACE2 might block COVID-19 viral entry. Some also hypothesized that some of the effects of COVID-19 might be driven by the virus activating the receptor during infection and increasing angiotensin II (AngII) production, which constricts arteries, promotes thrombosis, and triggers inflammation and respiratory distress. Countering these effects might therefore make the virus less deadly.

Biophytis therefore sought to repurpose BIO101 against COVID through its effects on the MAS receptor. Indeed, an independent group had previously reported that a 20-hydroxyecdysterone extract had protected mice against lung damage and reduced multiple inflammatory mediators in a lipopolysaccharide-induced acute lung injury mouse model.

In April 2020, Biophytis announced the launch of the Phase II/III COVA clinical trials to test BIO101 for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.

Biophytis’ press release was ambiguous as to whether it had already secured approval from the French National Agency for the Safety of Medicines (ANSM) or was merely awaiting it; the company said it would then extend the trial to Belgium and the United States. Indeed, Biophytis announced approval to begin the trial in Belgium from the Belgian Regulatory Agency (FAMHP) the following month, and from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June of 2020.

Per its Clinicaltrials.gov entry, the Phase II/III COVA trial (NCT04472728) was completed in September 2022. According to the subsequent publication, only 238 of the intended 310 patients were randomized due to low recruitment.

In January 2024, Biophytis announced the publication of COVA. COVA was a double-blind, randomized, placebo-controlled trial of BIO101 versus placebo in adults hospitalized with severe COVID-19, alongside standard of care (including treatment with glucocorticoids such as dexamethasone). Treatment continued for up to 28 days or until an endpoint was reached (mortality or respiratory failure requiring high-flow oxygen, mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or recovery and discharge).

Of the subjects randomized, 233 actually received study medication, and 194 completed the trial. Of those who received medication, subjects who received BIO101 were 11.4% less likely to suffer respiratory failure or early death by day 28 than were those who received the placebo, and they were 44.6% less likely to die by the 90-day mark. Additionally, 80.1% of BIO101-treated subjects were discharged by day 28, versus 70.9% in the placebo group, although this difference was not statistically significant.

In December 2023, Biophytis announced that it had reached an agreement for a partnership with the University of Liège to conduct preclinical studies on the effect of BIO101 in respiratory failure caused by influenza A.

In September 2024, Biophytis summarized its discussions with the European Medicines Agency (EMA) and FDA to clarify their requirements for an application for marketing authorization and probing their appetite for expanding BIO101’s eventual license to include all viral respiratory diseases rather than COVID-19 exclusively.

The last capture of Biophytis’ now-withdrawn dedicated web page on its COVA program, dated July 7, 2025, stated that the company would submit filings “in the coming months” “to obtain early accesss for BIO101 for COVID-19. They additionally reaffirmed their intention to pursue a wider indication for “other viral infections, such as seasonal influenza,” which might include the launch of an additional Phase III study, contingent on partnership agreements with an unnamed pharmaceutical company or companies.

The current ‘other projects’ pipeline page lists BIO101 as having completed Phase III trials and awaiting regulatory filings.