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A Multicentric, International, Randomized, Double-Blind, Placebo-Controlled, Phase II/III (MYODA-INT) Study to Evaluate the Safety and Efficacy of a Sarconeos Dose in Ambulant Boys with Duchenne Myopathy

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Trial Profile

A Multicentric, International, Randomized, Double-Blind, Placebo-Controlled, Phase II/III (MYODA-INT) Study to Evaluate the Safety and Efficacy of a Sarconeos Dose in Ambulant Boys with Duchenne Myopathy

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 24 Mar 2023

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At a glance

  • Drugs Sarconeos (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms MYODA-INT
  • Sponsors Biophytis

Most Recent Events

  • 20 Mar 2023 According to a Biophytis media release, with an Orphan Drug Designation already granted in both US and EU, company will meet with the FDA for a Type C meeting and EMA for Scientific Advice, in Q2 2023, to discuss and align with the clinical strategy that will support the development of BIO101 in DMD.
  • 20 Mar 2023 According to a Biophytis media release, company intends to start this trial in 2023.
  • 20 Mar 2023 According to a Biophytis media release, company will be sharing recent updates from this trial and therapeutic potential of BIO101 in Rare Neuromuscular Diseases during the MDA Clinical & Scientific Conference to be held in Dallas, Texas, March 19-22, 2023.

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