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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: 11 Nov 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

  • 02 Oct 2025 According to an iECURE media release, company to present updated result data from this study at the American Society of Human Genetics (ASHG) Annual Meeting, taking place October 14-18 in Boston.
  • 02 Oct 2025 According to an iECURE media release, company to present updated result data from this study at the European Society of Gene & Cell Therapy (ESGCT) Annual Congress, taking place October 7-10, 2025 in Sevilla, Spain.
  • 07 Aug 2025 According to an iECURE media release, the OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain, and iECURE expects to complete enrollment in 2025 and anticipates complete data from the trial in the first half of 2026.

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