AGLE - Aeglea completes patient randomization in late-stage pegzilarginase trial

Aeglea BioTherapeutics (AGLE) announces that it has completed patient randomization for PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints), the pivotal Phase 3 clinical trial investigating pegzilarginase for the treatment of Arginase 1 Deficiency ((ARG1-D)).ARG1-D is a rare, progressive disease characterized by high levels of arginine which results in severe mobility limitations due to spasticity, seizures, developmental delay, intellectual disability and early mortality.The company expects topline data from the trial in the fourth quarter of 2021.The trial is a global, randomized, double-blind trial designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks, with the primary endpoint of assessing of plasma arginine reduction from baseline.Previous studies have showed that plasma arginine control has the potential to improve the clinical status and to slow disease progression in patients with ARG1-D, the company said.

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Aeglea completes patient randomization in late-stage pegzilarginase trial