The US Food and Drug Administration (FDA) has accepted biopharmaceutical company Aeglea BioTherapeutics, Inc's investigational new drug (IND) application for AEB1102 for the treatment of solid tumours.

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 tumours 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,” 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.