Rare disease specialist Aeglea BioTherapeutics has announced both a leadership transition and corporate restructuring, with the goal of focusing resources on its clinical stage Homocystinuria treatment.
The restructuring will reduce the headcount of the Texas-based company resulting in an approximately 25% reduction year-to-date. Aeglea says it also plans to realize additional cost savings by transitioning patients out of the ongoing extension studies of pegzilarginase in Arginase 1 Deficiency while it engages with the FDA on a regulatory path forward.
The FDA issued Aeglea a refusal-to-file letter back in June in response to the company’s application for pegzilarginase. In the RTF letter, the agency requested additional data to support effectiveness and additional information relating to CMC.
Now, Aeglea is shifting its focus and resources towards a second rare disease candidate, AGLE-177. The novel recombinant human enzyme is currently being studied in a phase 1/2 trial for the treatment of patients with Classical Homocystinuria, a rare inherited disorder in which the body is unable to process certain building blocks of proteins (amino acids ) properly.
In conjunction with the restructuring announcement, the biotech also revealed that its CEO, Dr. Anthony Quinn, has stepped downed from his current position and transitioned into an advisory role. Aeglea’s current general counsel, Jim Kastenmayer, will serve as interim president and CEO while the company searches for a permanent replacement.