Anthony Quinn has stepped down from his role as chief executive officer and transitioned to an advisory role. Jim Kastenmayer, general counsel, will assume the post on an interim basis.
Changes in the form of layoffs and new leadership have come to Aeglea Biotherapeutics. Wednesday morning, the Texas-based company announced that Anthony Quinn has stepped down from his role as chief executive officer and transitioned to an advisory role.
The company also announced a 25 percent reduction in headcount under restructuring efforts to date.
The changes hit Aeglea two months after the FDA issued a Refusal to File Letter in response to the company’s Biologics License Application for pegzilarginase filed in April. As BioSpace reported at the time, the FDA called for additional data demonstrating a “treatment effect on clinically meaningful outcomes.” In its announcement, Aeglea said it will transition patients from ongoing extension studies of pegzilarginase in Arginase 1 Deficiency while it engages with the FDA on a regulatory path forward.
Under the new restructuring plan, Aeglea will focus its finances and prioritize the development of AGLE-177 for patients living with homocystinuria. AGLE-177 is currently being assessed in a Phase I/II trial for patients with classical homocystinuria, a rare inherited disorder of methionine metabolism. The condition results in elevated levels of total homocysteine, an amino acid that plays a key role in multiple progressive and serious disease-related complications. Preclinical data demonstrated that AGLE-177 improved important disease-related abnormalities and survival. The drug has received U.S. and EU Orphan Drug Designation and U.S. Rare Pediatric Disease Designation.
“The restructuring announced today increases the operational focus and capital deployment towards success of the AGLE-177 program in homocystinuria,” Russell J. Cox, chair of the board of directors of Aeglea said in a statement. He added that the company believes “focused execution of the current Phase I/II trial and its transition to late-stage development are key strategic priorities for Aeglea.”
As Quinn transitions into the company adviser role, Jim Kastenmayer, Aeglea’s general counsel, will assume the interim role of president and CEO. Aeglea has initiated a search for a new CEO.
“I and the rest of the organization are excited to continue our work and focus on our mission to change lives by bringing innovative therapies to underserved rare disease communities. Delivering data from our Phase I/II trial for AGLE-177 later this year is our near-term focus in advancing this mission,” Kastenmayer said in a statement.
Cox touted Quinn’s leadership role at Aeglea. He noted that under Quinn’s guidance, the company filed its first BLA, which resulted in the FDA’s RTF letter.
“Under his leadership, Aeglea has made substantial progress over the last five years with programs for ARG1-D and homocystinuria in clinical development and a research pipeline of other human enzyme-based therapeutics. He has built a strong, capable team with the experience to advance AGLE-177 through clinical and commercial development,” Cox said. “Aeglea will continue to benefit from Anthony’s scientific and clinical expertise, and I look forward to working with Anthony in his new role as an advisor to the company.”
In addition to Quinn’s departure, Aeglea announced that Michael Hanley, the company’s chief commercial officer, has been named chief business officer under the restructuring plan.
