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A 3-part, Randomized, Double Blind, Adaptive Seamless Phase 1-3 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of BIO101 in Non-Ambulatory Patients with a Genetically Confirmed Diagnosis of Duchenne Muscular Dystrophy and Evidence of Respiratory Deterioration

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Trial Profile

A 3-part, Randomized, Double Blind, Adaptive Seamless Phase 1-3 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of BIO101 in Non-Ambulatory Patients with a Genetically Confirmed Diagnosis of Duchenne Muscular Dystrophy and Evidence of Respiratory Deterioration

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Apr 2023

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At a glance

  • Drugs Sarconeos (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Proof of concept; Therapeutic Use
  • Acronyms MYODA-PK
  • Sponsors Biophytis

Most Recent Events

  • 18 Apr 2023 According to a Biophytis media release, the company thoroughly revised the protocol and propose a phase 1/2 study for non-ambulatory DMD patients with signs of deteriorating lung function. The company expect to submit this new protocol to the competent authorities in the second half of 2023.
  • 22 Oct 2021 Planned End Date changed to 23 Mar 2023.
  • 22 Oct 2021 Status changed from planning to recruiting.

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