Shots:

• Pivotal P-III study (PEACE: Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints), met 1EP with 80% reduction in plasma arginine at 24 wks along with positive trend in Gross Motor Function Measure Part E (GMFM-E) incl. ability to walk, run and jump
• Normal plasma arginine levels (40-115µM) were achieved in 90.5% in treatment arm, with square mean GMFM-E score improved by 4.2 units vs -0.4 units, mean 2MWT distance increased by 7.4mts vs1.9 mts. Pegzilarginase was well-tolerated and has no study discontinuations due to AEs
• Aeglea plans to file BLA with the USFDA in H1’22 and company is working with Immedica Pharma AB for commercialization in EU and certain ME countries, to file for MAAs across mentioned geographies

Ref: Aeglea | Image: Aeglea