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A Multicenter, Open-Label Extension Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001

Trial Profile

A Multicenter, Open-Label Extension Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 16 Dec 2019

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At a glance

  • Drugs Suvodirsen (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions
  • Sponsors WaVe life Sciences
  • Most Recent Events

    • 16 Dec 2019 According to a WaVe life Sciences media release, Patients will have a final follow-up visit, but no further doses will be administered, and patients will no longer undergo muscle biopsies.
    • 16 Dec 2019 Status changed from recruiting to discontinued, according to a WaVe life Sciences media release.
    • 16 Dec 2019 According to a WaVe life Sciences media release, the company is discontinuing the development of suvodirsen for patients with Duchenne muscular dystrophy (DMD) who have mutations amenable to exon 51 skipping, based on the interim data from this study because there is no change from baseline in dystrophin expression, as measured by western blot, with either the 3.5 mg/kg or 5 mg/kg doses of suvodirsen. No safety concerns or emerging safety signals were observed.
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