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An Open-label, Multicentre Extension Study to Evaluate the Long-Term Safety, Tolerability and Effects of Intravenous AEB1102 in Patients With Arginase I Deficiency Who Previously Received Treatment in Study CAEB1102-101A

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Trial Profile

An Open-label, Multicentre Extension Study to Evaluate the Long-Term Safety, Tolerability and Effects of Intravenous AEB1102 in Patients With Arginase I Deficiency Who Previously Received Treatment in Study CAEB1102-101A

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Mar 2024

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At a glance

  • Drugs Pegzilarginase (Primary) ; Pegzilarginase (Primary)
  • Indications Hyperargininaemia
  • Focus Adverse reactions
  • Sponsors Aeglea Biotherapeutics; Spyre Therapeutics
  • Most Recent Events

    • 22 Dec 2023 According to an Immedica media release, marketing authorization of Loargys (pegzilarginase) by the Medicines & Healthcare products Regulatory Agency in the UK is based on data from PEACE (CAEB1102-300A) and supported by this phase 2 open-label long-term study (CAEB1102-102A).
    • 27 Nov 2023 According to Spyre Therapeutics media release, Aeglea Biotherapeutics has changed its name to Spyre Therapeutics
    • 13 Oct 2023 According to an Immedica media release, based on data from this trial and supported by OLE (CAEB1102-102A), Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization of Loargys (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D) in patients two years and older. The positive opinion from the CHMP is now referred to the European Commission for a decision.
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