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A Phase 1/2 Open-label Study in Patients With Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102

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Trial Profile

A Phase 1/2 Open-label Study in Patients With Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 24 Jan 2024

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At a glance

  • Drugs Pegzilarginase (Primary)
  • Indications Hyperargininaemia
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors Aeglea Biotherapeutics; Spyre Therapeutics

Most Recent Events

  • 27 Nov 2023 According to Spyre Therapeutics media release, Aeglea Biotherapeutics has changed its name to Spyre Therapeutics
  • 12 Apr 2023 According to an Aeglea Biotherapeutics media release, a Marketing Authorization Application (MAA) for pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D) is under review with the European Medicines Agency with a possible approval decision in late 2023. The MAA was submitted by Immedica Pharma AB, Aeglea's commercialization partner in some countries in Europe and the Middle East.
  • 02 Mar 2023 According to an Aeglea Biotherapeutics media release, PEACE LTE and Phase 1/2 OLE studies were closed in the first quarter of 2023.

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