ABOUT
We take a focused approach to human enzyme therapies to bring about change for families with rare metabolic
diseases.
At Aeglea, we believe that every patient deserves a chance at a better life. We are committed to helping people with rare and devastating metabolic diseases who have limited treatment options because having a rare disease doesn’t mean that you are in this fight alone.
We are building a pipeline of novel therapies designed to modulate the chemical imbalances that drive disease. In 2021, we announced achievement of the primary endpoint in our Phase 3 study of pegzilarginase in patients with Arginase 1 Deficiency. By leveraging our unique protein engineering expertise to develop human enzyme medicines, we aim to bring balance to the lives of patients and their families and create hope for a better tomorrow.
We aspire to redefine the possible, to pioneer bold science with human enzymes and to deliver groundbreaking medicines that transform lives.
OUR HISTORY
Since our launch, we’ve made consistent progress towards our goal of delivering life-changing medicines to patients with rare metabolic diseases.
2022
- Marketing Authorization Application for pegzilarginase for the treatment of ARG1-D validation for review by the European Medicines Agency
2021
- Announced achievement of the primary endpoint in PEACE, a Phase 3 Study of pegzilarginase in patients with Arginase 1 Deficiency
- Entered a commercialization agreement with Immedica for pegzilarginase for the treatment of Arginase 1 Deficiency in Europe and certain countries in the Middle East
- Dosed first patient in Phase 1/2 clinical trial of pegtarviliase in patients with Homocystinuria
2020
- Aeglea opened new and expanded corporate offices in Austin, TX
- Aeglea announced positive long-term data for pegzilarginase for the treatment of ARG1-D
- FDA granted Orphan Drug and Rare Pediatric Disease Designations to pegtarviliase; EMA also granted Orphan Drug Designation
2019
- Aeglea initiated PEACE, a pivotal Phase 3 trial of pegzilarginase for the treatment of ARG1-D
- FDA granted Breakthrough Therapy Designation for pegzilarginase
2018
- Aeglea presented positive data from the Phase 1/2 clinical trial of pegzilarginase for the treatment of ARG1-D
- FDA granted Rare Pediatric Disease Designation for pegzilarginase
2017
- Aeglea presented first data on the treatment of ARG1-D patients with pegzilarginase
- Aeglea dosed the first pediatric patient in a Phase 1/2 trial of pegzilarginase for the treatment of ARG1-D
2013-2016
- Aeglea raised $55 million in a successful Initial Public Offering (NASDAQ: AGLE)
- Aeglea dosed the first patient in a Phase 1 trial of pegzilarginase for the treatment of ARG1-D
- The FDA granted Fast Track Designation and the EMA granted Orphan Drug Designation for pegzilarginase
- Aeglea was formed to build a platform of novel human enzyme therapeutics, initially using molecules from the lab of Professor George Georgiou, Ph.D., University of Texas at Austin
Advancing Multiple Development Programs
