Aeglea BioTherapeutics Announces Positive Interim Clinical Data and Completion of Enrollment for Ongoing Phase 1/2 Trial of Pegzilarginase

Aeglea BioTherapeutics (NASDAQ: AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, today announced completion of enrollment and additional clinical data at the 2018 Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium from its ongoing Phase 1/2 trial of pegzilarginase, its lead investigational therapy, in patients with the rare genetic disease Arginase 1 Deficiency (ARG1-D).

As quoted in the press release:

“I am thrilled that we exceeded our recruitment target in this Phase 1/2 trial of pegzilarginase by five patients, as enrollment completion is an important milestone for patients with ARG1-D,” said Anthony G. Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “We are pleased to confirm our previous guidance of announcing the design of the first pivotal clinical trial for patients with ARG1-D in the fourth quarter of 2018 and initiating the pivotal trial in the first half of 2019.”

“Given the challenges of lowering arginine levels with current approaches, it is very encouraging to see the marked reductions in plasma arginine in our patient following treatment with pegzilarginase,” said George Diaz, M.D., Ph.D, professor and chief, Division of Medical Genetics, Icahn School of Medicine at Mount Sinai, and co-author on the presentation. “In addition, it is very exciting that we are seeing evidence of an impact on important disease manifestations with better walking, improved posture, and enhanced alertness.”

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