Sarconeos (BIO101), developed by Biophytis, is a drug molecule designed to combat sarcopenia. It promotes muscle regeneration and the maintenance of muscle strength by stimulating muscle protein synthesis and energy production, via the MAP kinase signalling pathways.
The FDA has given its approval in the United States for the MYODA plan, in the context of an adaptive design trial, evaluating Sarconeos. This clinical development plan, supported by AFM-Téléthon, has been the subject of preclinical studies conducted in models of mice with DMD being treated with Sarconeos (BIO101). The studies have shown a positive effect of the product on muscle function, mobility and respiratory function.
Biophytis has submitted an authorisation application to put in place its clinical development plan, intended to assess Sarconeos (BIO101) in children with Duchenne muscular dystrophy. The FDA has just given its approval to start this plan in the United States. MYODA provides for a continuous clinical trial protocol from phase I to phase III, allowing the safety and efficacy (using a composite score) of the product to be assessed. This plan should begin in 2020. The application for authorisation in France will be submitted end of 2019.
Access Biophytis press release 16/12/19 Biophytis Receives FDAApproval toProceed with the MYODA Program forClinical Development of Sarconeos (BIO101) in Patients with Duchenne Muscular Dystrophy (DMD)
