80% plasma arginine reduction (primary endpoint; p < 0.0001) accompanied by a positive trend in GMFM-E, a key clinical assessment of patient mobility
90.5% of patients achieved normal plasma arginine levels
Pegzilarginase was well-tolerated; no discontinuations due to adverse events
First potential therapy to address key driver of ARG1-D, a devastating ultra-rare disease
Plan to submit BLA in first half of 2022
Company to host conference call and webcast today at 8:00am EST
AUSTIN, Texas, Dec. 6, 2021 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced that the pivotal Phase 3 study, PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints), met the primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p