MRO Magazine

Aeglea BioTherapeutics Announces FDA Acceptance of Its Investigational New Drug Application for AEB1102 for the Treatment of Arginase I Deficiency


January 7, 2016
By Business Wire News

AUSTIN, Texas

Aeglea BioTherapeutics, Inc., a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat inborn errors of metabolism and cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application for AEB1102 for the treatment of Arginase I deficiency, a urea cycle disorder that results in elevated levels of the amino acid arginine, which can lead to a range of complications including intellectual disability and spasticity. Aeglea intends to initiate a Phase 1 dose escalation study designed to assess the safety, tolerability, and pharmacokinetics of AEB1102 in patients with this inborn error of metabolism in the first half of 2016.

“The acceptance of our second IND for AEB1102 is an important milestone for the company as we continue to drive forward the development of this product candidate,” said David G. Lowe, Ph.D., co-founder, president and chief executive officer of Aeglea. “Arginase I deficiency is a serious disease that currently has no approved treatment options, aside from dietary restriction, and we are committed to developing AEB1102 to potentially address this unmet medical need.”

AEB1102 is an engineered human enzyme designed to degrade the amino acid arginine and in nonclinical studies has demonstrated the ability to reduce blood arginine levels. In addition to being developed as a potential treatment for Arginase I deficiency, AEB1102 is currently being investigated in a Phase 1 study to treat solid tumors.

About Aeglea BioTherapeutics

Aeglea is a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat inborn errors of metabolism and cancer. The company’s engineered human enzymes are designed to degrade specific amino acids in the blood in order to reduce toxic levels of amino acids in inborn errors of metabolism or to exploit the dependence of certain cancers on specific amino acids. In addition to the ongoing Phase 1 clinical trial in oncology with its lead product candidate AEB1102, Aeglea expects to begin trials in 2016 of AEB1102 in patients with Arginase I deficiency. The company is building a pipeline of additional product candidates targeting key amino acids, including AEB4104, which degrades homocystine, a target for an inborn error of metabolism, as well as two potential treatments for cancer, AEB3103, which degrades cysteine/cystine, and AEB2109, which degrades methionine.

For more information, visit http://aegleabio.com.

BrewLife
Kelly France, Ph.D., 415-946-1076
kfrance@brewlife.com