FDA grants Aeglea's lead therapy pegzilarginase (polyethyl glycol arginase) breakthrough drug

Aeglea BioTherapeuticscompany(http:// announcedthat the U.SFood andDrug(http://Administration (
FDA(http://) has granted the lead therapy pegzilarginase (polyglycol arginase) to treat arginine 1 deficiency (ARG1-D) breakthrough drug eligibility (BTD)The FDA grant of pegzilarginase BTD is based on data from Phase I/II studies conducted in PATIENTs with ARG1-D and the ongoing Phase II Open Label Extension StudyAeglea expects to continue discussions with the FDA on the Pegzil Arginase project and next steps in the fourth quarter of 2019About pegzilarginase
pegzilarginase is an enhanced human arginine enzyme that can enzyme-desify the consumption of arginine Currently, Aeglea is developing pegzilarginase for the treatment of patients with arg1 deficiency (ARG1-D) 　　ARG1-D can lead to two key metabolic effects: high levels of arginine and arginine-derived metabolites, urea cycle damage In terms of treatment, the best treatment available to reduce plasma arginine is dietary protein limits, but compliance is a difficult challenge, and poor compliance often leads to disease progression and premature death 　　Pegzilarginase is an enzyme replacement therapy used to lower elevated levels of arginine in a patient's blood The evaluation of Pegzilarginase for treatment of ARG1-D patients in Phase I/II and The Phase II Open Label Extension Study showed clinical improvement and a continued decline in plasma arginine 　　Currently, Aeglea is recruiting patients for a single globalcritical Phase III PEACE study to assess the efficacy and safety of pegzilarginase relative to placebo treatment for 24 weeks, with a decrease in plasma arginine relative to baseline levels