Aeglea BioTherapeutics Doses First Patient in Phase 3 Trial of Pegzilarginase in Arginase 1 Deficiency

Aeglea BioTherapeutics (NASDAQ:AGLE) has announced the first patient in its Phase 3 PEACE trial has been dosed.

As quoted in the press release:

The pivotal trial is intended to further evaluate the efficacy and safety of pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D), a progressive disease presenting in early childhood that results in severe complications and early mortality. The Company expects to report topline data from the PEACE trial in the first quarter of 2021. Aeglea anticipates reporting new data in September 2019 from all patients who have each received at least 20 doses in the Company’s ongoing Phase 1/2 extension study.

“Aeglea is reminded daily of the challenges patients with ARG1-D face due to the limitations of current disease management,” said Anthony G. Quinn, M.B. Ch.B, Ph.D., president and chief executive officer of Aeglea. “The dosing of our first patient in the pivotal Phase 3 PEACE trial is a major step in establishing the clinical effectiveness of pegzilarginase. Aeglea is committed to working with physicians, patients, caregivers, and the ARG1-D community as we advance this potentially transformative therapy for patients with this devastating and progressive disease.”

“We are excited to be involved in the PEACE trial as it provides us the opportunity to build on our experience and data from the Phase 1/2 trial, where we observed excellent control of arginine levels and stability or improvement in mobility and adaptive behavior,” said Markey McNutt, M.D., Ph.D. an assistant professor with the Eugene McDermott Center for Human Growth and Development at UT Southwestern.

Click here to read the full press release.