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A Phase I/II, Open-label, Dose Escalating With 48 Week Treatment Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of BMN053 (Previously Known as PRO053) in Subjects With Duchenne Muscular Dystrophy.

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Trial Profile

A Phase I/II, Open-label, Dose Escalating With 48 Week Treatment Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of BMN053 (Previously Known as PRO053) in Subjects With Duchenne Muscular Dystrophy.

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs PRO 053 (Primary) ; PRO 053 (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Therapeutic Use
  • Sponsors BioMarin Nederland; BioMarin Pharmaceutical

    • Most Recent Events

    • 31 May 2016 According to a BioMarin media release, the company intends to discontinue clinical and regulatory development of Kyndrisa as well as the three other first-generation follow-on products, BMN 044, BMN 045 and BMN 053, currently in Phase 2 studies for distinct forms of Duchenne muscular dystrophy.
    • 31 May 2016 Status changed from active, no longer recruiting to discontinued, according to a BioMarin media release.
    • 06 Jun 2015 Planned number of patients changed from 42 to 45 as reported by ClinicalTrials.gov record.
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