Benzinga | Nov 4, 2021 07:12AM EDT

Aeglea BioTherapeutics Announces Presentation Of 7 Abstracts At ICIEM 2021 Including Oral Presentation Of PEACE Study Baseline Characteristics

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 that seven abstracts will be presented at the 14th International Congress of Inborn Errors of Metabolism (ICIEM) 2021 being held November 21-23, 2021. The series of abstracts illustrate the building interest and knowledge around the clinical impact of Arginase 1 Deficiency (ARG1-D), the importance of increased disease awareness to drive more rapid and accurate diagnosis and the need for improved treatments given the significant limitations of the current standard of care. The data will be presented at ICIEM in advance of the topline data readout for the pivotal Phase 3 PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints) study expected in December.

Key highlights include the first presentation of the baseline characteristics of patients participating in the PEACE study (Enns et al), a growing body of evidence that implicates high arginine as the primary driver of disease pathology (Diaz et al), and several individual patient case studies that reveal the long-term challenges faced by patients with ARG1-D from diagnosis to death. Taken together, the presentations at ICIEM emphasize the need for therapies that reduce and maintain control of plasma arginine levels in patients with ARG1-D.

"We are extremely pleased to have such a strong presence at ICIEM this year. This collection of abstracts provides a clear framework for understanding the devastating impact of ARG1-D and the challenges diagnosing and treating patients with this condition," said Eric Bradford, M.D., M.B.A., chief development officer at Aeglea. "The long-term studies of individual patients and other presentations, which highlight the role of arginine and define the hallmarks of the disease, tell a compelling story about the unmet need, the importance of managing plasma arginine levels and the potential advance that pegzilarginase represents. In addition, the presentation of the baseline characteristics at ICIEM sets the stage for the topline results from PEACE, which will be the first controlled study of an investigative therapy for this progressive and debilitating disorder."