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
Price :
$35
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At a glance
- Drugs Sarconeos (Primary)
- Indications Duchenne muscular dystrophy
- Focus Registrational; Therapeutic Use
- Acronyms MYODA-INT
- Sponsors Biophytis
- 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.