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
Price :
$35
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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
- 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.