Aeglea Announces FDA Acceptance Of Its Investigational New Drug Application For AEB1102 For The Treatment Of Hematological Malignancies

AUSTIN, Texas--(BUSINESS WIRE)--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, an engineered human enzyme designed to degrade the amino acid arginine, for the treatment of patients with hematological malignancies. In the first half of 2016, Aeglea intends to initiate a Phase 1 dose escalation study in patients with relapsed and refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) to assess the safety, tolerability, and pharmacokinetics of AEB1102.

“This represents our third open IND for AEB1102, which is an exciting achievement for Aeglea, a company founded just over two years ago”

“This represents our third open IND for AEB1102, which is an exciting achievement for Aeglea, a company founded just over two years ago,” said David G. Lowe, Ph.D., co-founder, president and chief executive officer of Aeglea. “We look forward to starting our hematological malignancy Phase 1 clinical trial as we continue to expand the development of our lead product candidate in multiple indications.”

Many types of cancer, including several hematological malignancies, are believed to be dependent on arginine for growth and survival. AEB1102 has been shown to reduce blood arginine levels in nonclinical studies. In addition to being developed as a potential treatment for hematological malignancies, AEB1102 is currently being investigated in a Phase 1 trial for the treatment of patients with advanced solid tumors, and is also anticipated to begin enrollment for another Phase 1 trial for the treatment of Arginase I deficiency in the first half of 2016.

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 solid tumors with its lead product candidate AEB1102, Aeglea expects to begin trials in the first half of 2016 of AEB1102 in patients with Arginase I deficiency and hematological malignancies. 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.