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PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency

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Trial Profile

PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2024

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At a glance

  • Drugs Pegzilarginase (Primary) ; Pegzilarginase (Primary)
  • Indications Hyperargininaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms PEACE
  • Sponsors Aeglea Biotherapeutics; Spyre Therapeutics

Most Recent Events

  • 22 Dec 2023 According to an Immedica media release, the Medicines & Healthcare products Regulatory Agency in the UK has granted marketing authorization of Loargys (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininaemia, in adults, adolescents and children aged 2 years and older.
  • 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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