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A Phase I/II First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of a Single Intravenous (IV) Administration of ECUR-506 in Males Less Than 9 Months of Age With Genetically Confirmed Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

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Trial Profile

A Phase I/II First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of a Single Intravenous (IV) Administration of ECUR-506 in Males Less Than 9 Months of Age With Genetically Confirmed Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Mar 2025

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At a glance

  • Drugs ECUR 506 (Primary)
  • Indications Ornithine carbamoyltransferase deficiency disease
  • Focus Adverse reactions; First in man
  • Acronyms OTC-HOPE
  • Sponsors iECURE

    • Most Recent Events

    • 09 Jan 2025 According to an iECURE media release, Julien Baruteau is the principal investigator in the study and company look forward to engaging with regulatory agencies on potential accelerated approval pathway in 2025.
    • 09 Jan 2025 Results presented in the iECURE media release Media Release.
    • 09 Jan 2025 According to a Precision BioSciences media release, iECURE expects to finish enrollment in 2025 and provide complete data for the program in the first half of 2026.

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