Aeglea Announces FDA Acceptance Of Investigational New Drug Application For AEB1102

AUSTIN, Texas--(BUSINESS WIRE)--Aeglea BioTherapeutics, Inc., a biopharmaceutical 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 solid tumors. Aeglea intends to initiate a Phase 1 dose escalation study designed to assess the safety, tolerability, and pharmacokinetics of AEB1102 in patients with advanced solid tumors in the fourth quarter of 2015.

“The FDA’s acceptance of our IND is an important organizational milestone for Aeglea as we transition into a clinical-stage company”

“The FDA’s acceptance of our IND is an important organizational milestone for Aeglea as we transition into a clinical-stage company,” said David G. Lowe, Ph.D., co-founder, president and chief executive officer of Aeglea. “We are excited to see our lead product candidate advance into the clinic and move one step closer to bringing this novel therapy to patients in need of new treatment options.”

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. AEB1102 is being developed to treat cancers that have been shown to have a metabolic dependency on arginine, as well as the rare disease arginase I deficiency, which is caused by an inborn error of metabolism leading to toxic levels of arginine in blood.

About Aeglea BioTherapeutics

Aeglea is a biopharmaceutical 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. Aeglea’s lead product candidate, AEB1102 is engineered to degrade the amino acid arginine and is expected to enter clinical trials in 2015 in cancer and 2016 in arginase I deficiency. The company is building a pipeline of additional product candidates targeting key amino acids, including AEB4104, which degrades homocysteine, 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.