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Aeglea : Phase 3 Study Of Pegzilarginase On Arginase 1 Deficiency Meets Primary Endpoint

Aeglea BioTherapeutics Inc. (AGLE) said that the pivotal Phase 3 study, PEACE or 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.

The company stated that pronounced and sustained plasma arginine reduction was accompanied by a positive trend in Gross Motor Function Measure Part E (GMFM-E), a key clinical assessment of a patient's mobility, including the ability to walk, run and jump.

The company plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2022. In addition, Aeglea will work with Immedica Pharma AB, its commercial partner in Europe and certain countries in the Middle East, to submit marketing authorization applications in those territories.

The company noted that the study demonstrated a highly statistically significant 80% reduction in mean plasma arginine in pegzilarginase treated patients, the primary endpoint of the trial. Normal plasma arginine levels (40-115µM) were achieved in 90.5% of pegzilarginase treated patients compared to none of the patients in the placebo arm.

Pegzilarginase is a novel recombinant human enzyme engineered to degrade the amino acid arginine and which has been shown to rapidly and sustainably lower levels of the amino acid arginine in plasma.

Aeglea is developing pegzilarginase for the treatment of people with Arginase 1 Deficiency (ARG1-D), a rare debilitating and progressive disease characterized by the accumulation of arginine. ARG1-D presents in early childhood and patients experience spasticity, seizures, developmental delay, intellectual disability and early mortality.

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