Aeglea BioTherapeutics (NASDAQ:AGLE) has presented positive 20-dose data on 14 patients from its completed Phase 1/2 trial and ongoing Phase 2 open-label extension (OLE) trial for pegzilarginase in patients with Arginase 1 Deficiency (ARG1-D) at the 2019 Symposium of the Society for the Study of Inborn Errors of Metabolism.
Data from all patients continued to demonstrate marked and sustained reductions in plasma arginine.
79% (11 of 14) of patients were clinical responders, using mobility assessment components that correspond with the pivotal PEACE trial secondary endpoint.
Pegzilarginase was well tolerated and the rates of treatment-related adverse events decreased over time.
The Company expects to continue discussions with the FDA on the pegzilarginase program and next steps in Q4 2019 or Q1 2020.
Topline data from the PEACE trial is expected in Q1 2021.
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