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Aeglea BioTherapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Corporate Highlights
Phase 3 PEACE Study Enrollment Expected to Complete in March; Topline Data Expected in Fourth Quarter Received U.S. Rare Pediatric Disease Designation for
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"Phase 3 PEACE Study Enrollment Expected to Complete in March; Topline Data Expected in Fourth Quarter\n Received U.S. Rare Pediatric Disease Designation for AGLE-177 for the Treatment of Homocystinuria, Eligible for Priority Review Voucher\n\n\nAUSTIN, Texas, March 18, 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 reported its fourth quarter and full year 2020 financial results, and provided recent corporate and program highlights.\n\"2020 was a challenging year advancing our clinical trials and at the same time prioritizing the health and well-being of the rare disease patients we serve, who often have additional difficulties and vulnerabilities,\" said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. \"We have been focused on mitigating the impact of COVID-19 on our clinical timelines and I'm proud of the work the team has done to put patient needs first while also advancing a broad range of other impactful activities, as seen with the regulatory designations received for AGLE-177, our continuous gains in Arginase 1 Deficiency patient identification and the buildout of our commercial organization.\" \nDr. Quinn continued, \"With enrollment completion expected this month and data expected in the fourth quarter for our pivotal Phase 3 PEACE study of pegzilarginase in Arginase 1 Deficiency, and the potential for first-in-human data from our AGLE-177 Phase 1/2 clinical trial in Homocystinuria, 2021 is shaping up to be a transformational year and we are well positioned to evolve into a successful commercial-stage company.\"\nRecent Highlights and Updates\nPegzilarginase in Arginase 1 Deficiency\nAs of mid-March, 24 patients have been enrolled and randomized in the pivotal Phase 3 PEACE clinical trial. An additional nine patients are in active screening or scheduled to begin screening in the next two weeks. Trial enrollment is expected to close in March, with completion of screening and all patients randomized by the end of April. Topline data is expected in the fourth quarter of 2021. As of January, Aeglea has identified over 300 Arginase 1 Deficiency patients in addressable markets. The number of currently identified patients re...