I am excited to share with you that today we announced our Phase 3 PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints) study achieved its primary endpoint with a statistically significant reduction in plasma arginine levels. Pronounced and sustained plasma arginine reduction was accompanied by a positive trend in the Gross Motor Function Measure Part E (GMFM-E), a key clinical assessment of patient mobility.
Based on these encouraging results, we plan to submit a Biologics License Application (BLA) to the FDA in the first half of 2022. Your dedication to the Arginase 1 Deficiency community is inspiring and we look forward to working with you to meet the needs of those living with this disease. Please be sure to share our heartfelt gratitude with the broader ARG1-D community – particularly those patients, families and healthcare professionals who participated in our clinical trials.
Our public announcement can be viewed via our press release. https://ir.aeglea.com/press-releases/news-details/2021/Aeglea-BioTherapeutics-Announces-Achievement-of-Primary-Endpoint-in-Phase-3-Study-of-Pegzilarginase-in-Patients-with-Arginase-1-Deficiency/default.aspx