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Biophytis – Sarconeos (BIO101) for Duchenne muscular dystrophy

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).

BIO101 (AKA Sarconeos and Ruvembri) for Duchenne Muscular Dystrophy FDA granted Biophytis IND approval in December 2019 to initiate a Phase 1/2 clinical proof of concept trial (MYODA-INT) of an oral pediatric formulation of  BIO101, using a ‘seamless’ clinical trial design with composite clinical endpoints. This trial was expected to begin early in 2023 with the aim of treating Duchenne muscular dystrophy (DMD).