Aeglea BioTherapeutics Announces Presentation of Additional Data from PEACE Phase 3 Study of Pegzilarginase for the Treatment of Arginase 1 Deficiency at the Society for Inherited Metabolic Disorders Annual Meeting

Rhea-AI Summary

Aeglea BioTherapeutics (AGLE) announced upcoming presentations at two medical meetings, showcasing data from its PEACE Phase 3 study of pegzilarginase for Arginase 1 Deficiency (ARG1-D). The Society for Inherited Metabolic Disorders Annual Meeting will feature results from the trial, scheduled for April 11, 2022. Additional posters will be presented at the American Academy of Neurology Annual Meeting, focusing on ARG1-D management and the role of arginine. The company recently reported positive topline data from the trial, which received Rare Pediatric Disease and Breakthrough Therapy Designations.

Positive

• Upcoming presentations at two major medical meetings to share data on pegzilarginase.
• Positive topline data from PEACE Phase 3 trial announced in December 2021.
• Pegzilarginase received Rare Pediatric Disease and Breakthrough Therapy Designations.

Negative

• None.

AUSTIN, Texas, March 29, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced poster presentations at two upcoming medical meetings. The Company will present additional data from the PEACE Phase 3 study of pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D) at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting in Orlando, FL. Additionally, two encore posters describing the management of ARG1-D and the role of arginine as a key driver of the disease will be presented at the American Academy of Neurology (AAN) Annual Meeting in Seattle, WA and virtually.

Society for Inherited Metabolic Disorders Annual Meeting (April 10-13, 2022)
Title: Pegzilarginase in Arginase 1 Deficiency: Results of the PEACE Pivotal Phase 3 Clinical Trial
Abstract: #30
Session: Scientific Session 5
Presentation time: Monday, April 11 from 7-8pm PDT
Presenter: Eric Bradford, MD, MSc, MBA, chief development officer at Aeglea BioTherapeutics

American Academy of Neurology Annual Meeting (Live: April 2-7, 2022; Virtual: April 24-26, 2022)
Title: Management and Progression of Arginase 1 Deficiency Over 2 Decades of Follow-Up
Abstract: 003
Session: P11
Presentation time: Tuesday, April 5 from 11:45am-12:45pm EDT
Presenter: Deborah Marsden, MBBS, FAMCGG, MRCP(UK), attending physician, Division of Genetics and Genomics at Boston Children's Hospital

Title: Arginine: The Key Driver of Pathophysiology and Progression in Arginase 1 Deficiency
Abstract: 004
Session: P11
Presentation time:  Tuesday, April 5 from 11:45am-12:45pm EDT
Presenter: Mark Bechter, BM, vice president of medical affairs at Aeglea BioTherapeutics

About Aeglea BioTherapeutics Aeglea BioTherapeutics is a clinical-stage biotechnology company redefining the potential of human enzyme therapeutics to benefit people with rare metabolic diseases with limited treatment options. In December 2021, Aeglea announced positive topline data from its PEACE Phase 3 clinical trial for its lead product candidate, pegzilarginase, in patients with Arginase 1 Deficiency. Pegzilarginase has received both Rare Pediatric Disease and Breakthrough Therapy Designations. Aeglea also has an ongoing Phase 1/2 clinical trial of AGLE-177 for the treatment of Homocystinuria. AGLE-177 has been granted Rare Pediatric Disease Designation. Aeglea has an active discovery platform focused on engineering small changes in human enzymes to have a big impact on the lives of patients and their families. For more information, please visit http://aeglea.com.

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SOURCE Aeglea BioTherapeutics, Inc.

FAQ

What is the PEACE Phase 3 study for pegzilarginase?

The PEACE Phase 3 study evaluates pegzilarginase for treating Arginase 1 Deficiency (ARG1-D), aiming to demonstrate its efficacy and safety.

When will the data from the PEACE Phase 3 study be presented?

Data from the PEACE Phase 3 study will be presented at the Society for Inherited Metabolic Disorders Annual Meeting on April 11, 2022.

What designations has pegzilarginase received?

Pegzilarginase has received Rare Pediatric Disease and Breakthrough Therapy Designations.

What are the implications of the positive topline data for AGLE shares?

Positive topline data may enhance investor confidence and potentially drive stock performance for AGLE as it indicates progress in clinical development.

What other studies are being conducted by Aeglea BioTherapeutics?

Aeglea is conducting an ongoing Phase 1/2 clinical trial of AGLE-177 for the treatment of Homocystinuria, which has also received Rare Pediatric Disease Designation.