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Aeglea BioTherapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Program Updates
Pegzilarginase BLA preparation on track to enable a second quarter 2022 submission to the FDA Accelerating Phase 1/2 trial of AGLE-177 for Homocystinuria;
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"Pegzilarginase BLA preparation on track to enable a second quarter 2022 submission to the FDA\n Accelerating Phase 1/2 trial of AGLE-177 for Homocystinuria; clinical data announcement expected in the second half of 2022\n $95 million of cash as of December 31, 2021, which is expected to fund operations into the first quarter of 2023\n\n\nAUSTIN, Texas, March 8, 2022 /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 financial results for the fourth quarter and full year 2021, and provided program updates.\n\"2021 moved us closer to our goal of delivering life-changing medicines to people with rare metabolic diseases with positive topline data from our pivotal Phase 3 trial of pegzilarginase for Arginase 1 Deficiency and the dosing of the first patients in our Phase 1/2 trial of AGLE-177 for Homocystinuria. We enter 2022 well positioned to capitalize on the momentum we've built,\" said Anthony Quinn, M.B., Ch.B., Ph. D., president and chief executive officer of Aeglea. \"We are excited about the opportunities in 2022 for a transformative year. With a strong portfolio of human enzyme therapies for rare metabolic diseases, we are looking forward to advancing all our programs, including sharing clinical data from our AGLE-177 program, progressing AGLE-325 for Cystinuria through IND-enabling studies and working with the FDA throughout the regulatory process for pegzilarginase.\"\nProgram Updates\nPegzilarginase in Arginase 1 Deficiency\nAnnounced the PEACE Phase 3 clinical trial met its primary endpoint with an 80% plasma arginine reduction, and an accompanying positive trend in a secondary endpoint assessing mobility. Additionally, 90.5% of patients achieved normal plasma arginine levels. Pegzilarginase was well-tolerated, and no patients discontinued the trial due to adverse events. Highlighted 104-week data from the GMFM-E and 6-Minute Walk Test assessments from the Phase 1/2 open-label extension, which underscores the sustained, long-term impact of pegzilarginase treatment on mobility. Plan to present additional data from PEACE Phase 3 clinical trial at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting in April 2022. Hosted a Key Opinion Lea...