Aeglea: FDA approves IND application
ATI company, 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.
Read full press release here.
Aeglea is part of ATI’s Bio/Health Sciences portfolio.