AGLE - Aeglea says pivotal trial for pegzilarginase in Arginase 1 Deficiency met main goal

Aeglea BioTherapeutics (NASDAQ:AGLE) announced that its Phase 3 pivotal trial for pegzilarginase in Arginase 1 Deficiency met the primary endpoint. However, a key measure designed to assess the patient's mobility have not achieved statistical significance. Aeglea (AGLE) have lost ~18.0% in the pre-market. In the 32-patient PEACE trial, the primary endpoint was to determine the plasma arginine reduction from baseline levels which was accomplished with statistical significance at an 80% decline after 24 weeks of the treatment (p <0.0001). 90.5% of patients who were treated with pegzilarginase achieved normal plasma arginine levels (40-115µM). The decline of plasma arginine was accompanied by a “positive trend” in Gross Motor Function Measure Part E (GMFM-E), a key measure to clinically assess the patient's mobility. While least squares mean GMFM-E score improved by 4.2 units for pegzilarginase arm, it worsened by 0.4 units in the placebo arm (p=0.1087; 95% CI [-1.1, 10.2]). The safety profile of

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Aeglea says pivotal trial for pegzilarginase in Arginase 1 Deficiency met main goal