Aeglea BioTherapeutics (AGLE) Initiates Dosing in Phase 1 Trial of AEB1102

September 15, 2016 8:05 AM EDT
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Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat genetic rare diseases and cancer, today announced the dosing of the first two patients in a Phase 1 trial of AEB1102, a recombinant human enzyme designed to degrade the amino acid arginine, for the treatment of patients with Arginase I deficiency.

“Initiating dosing of Aeglea's lead product candidate AEB1102 in two patients with this genetic rare disease is a key milestone as this is the first clinical trial of an enzyme replacement therapy for Arginase I deficiency. We took an important step forward for this patient community and the company as we continue to build on the momentum of this program after receiving both Orphan Drug Designation from the European Commission and Fast Track designation from the FDA earlier this year,” said David G. Lowe, Ph.D., co-founder, president and chief executive officer. “We now have three ongoing clinical trials investigating AEB1102 in a genetic rare disease, advanced solid tumors and hematological malignancies and look forward to presenting data in 2017.”

“If left untreated, Arginase I deficiency can be a devastating disease for patients and their families,” said Sandra Rojas-Caro, M.D., chief medical officer. “We believe AEB1102 has the potential to address this unmet medical need by acting on the underlying cause of the disease.”

Roberto Zori, M.D., professor and chief, Division of Genetics and Metabolism at the University of Florida and an investigator in the trial said, “We do not at this moment have any specific therapeutic available for our patients with Arginase I deficiency and we are therefore happy to participate in this effort to better understand the disease and to develop treatments for this condition.”

About the Trial

The Phase 1, multicenter, single arm, open label, dose escalation trial of AEB1102 will enroll up to six patients, 18 years of age or older, with Arginase I deficiency. The primary endpoint of the trial is safety and tolerability of intravenous administration of AEB1102 in patients with Arginase I deficiency. The trial will also evaluate the pharmacokinetic and pharmacodynamic effects of single ascending doses of AEB1102 including plasma arginine levels.

Please refer to for additional clinical trial details.

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