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Aeglea BioTherapeutics Reports Third Quarter 2022 Financial Results and Provides Program Updates
Interim Clinical Data from Phase 1/2 Trial of Pegtarviliase Expected in Fourth Quarter of 2022; Currently Dosing Cohort 3 at 1.35 mg/kg MAA for Pegzilarginase
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"Interim Clinical Data from Phase 1/2 Trial of Pegtarviliase Expected in Fourth Quarter of 2022; Currently Dosing Cohort 3 at 1.35 mg/kg \nMAA for Pegzilarginase for the Treatment of Arginase 1 Deficiency Accepted for Review by the EMA \n$75.2 Million of Cash as of September 30, 2022; Runway into Fourth Quarter of 2023\nAUSTIN, Texas, Nov. 3, 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 third quarter ended September 30, 2022 and provided program updates.\n\"With our recent corporate restructuring we have prioritized our pegtarviliase program to optimize our resources and maximize Aeglea's success. We continue to advance our Phase 1/2 trial of pegtarviliase for Classical Homocystinuria with the ongoing enrollment of cohort 3 and look forward to sharing interim data from this trial before the end of the year,\" said Jim Kastenmayer, Ph. D., J.D., interim chief executive officer and general counsel of Aeglea. \"While our primary focus is pegtarviliase, we are a multi-program company and are pleased that the Marketing Authorization Application for pegzilarginase for Arginase 1 Deficiency submitted by our valued partner Immedica is currently under review by the EMA for a potential approval next year. We view the progress in our portfolio as validation of what can be accomplished through our innovative human enzyme engineering platform and its potential to transform the lives of patients and families living with rare metabolic diseases.\"\nProgram and Corporate UpdatesPegtarviliase in Homocystinuria\nCurrently dosing Classical Homocystinuria patients in cohort 3 at 1.35 mg/kg once weekly via subcutaneous injection in the Phase 1/2 clinical trial.Plan to announce interim Phase 1/2 clinical data, including data from cohort 3, in the fourth quarter of 2022.Received a letter from the U.S. Food and Drug Administration (FDA) responding to a protocol amendment stating that patients aged younger than 18 years cannot currently be enrolled in the Phase 1/2 trial. The company believes the letter will have no impact on the timeline for the trial.Hosted a Key Opinion Leader (KOL) webinar discussing Classical Homocystinuria and providing an o...