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Aeglea BioTherapeutics Announces Leadership Transition and Corporate Restructuring

August 25, 2022

Aeglea BioTherapeutics, a clinical-stage biotechnology company developing enzyme therapeutics for rare metabolic diseases announced a leadership transition and corporate restructuring to focus resources on AGLE-177 in development for patients living with homocystinuria.

Anthony Quinn, president, CEO, and member of Aeglea’s board of directors, has stepped down from his current positions and transitioned to an advisory role effective immediately. The board of directors has appointed Jim Kastenmayer, the company’s current general counsel, as interim president and chief executive officer as it initiates a search for a permanent replacement. Additionally, the company’s chief commercial officer, Michael Hanley, has been appointed chief business officer with expanded responsibilities in internal business operations.

The restructuring has further reduced the headcount of the company resulting in an approximately 25 percent reduction year-to-date.

In June the U.S. Food and Drug Administration issued a refusal-to-file letter in response to a filing for approval of pegzilarginase for the treatment of arginase 1 deficiency, asking for additional data to support the effectiveness of the therapy.

In order to realize additional cost savings, Aeglea plans to transition 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 implementation of the restructuring plan will prioritize development of AGLE-177 and result in extending the company’s cash runway into the fourth quarter of 2023.

“The restructuring announced today increases the operational focus and capital deployment towards success of the AGLE-177 program in homocystinuria,” said Russell Cox, chairman of the board of directors of Aeglea. “We believe AGLE-177 has the potential to become the best-in-class treatment option for these patients and we believe focused execution of the current phase 1/2 trial and its transition to late-stage development are key strategic priorities for Aeglea.”

AGLE-177 is a novel recombinant human enzyme engineered to degrade the amino acid homocysteine and its dimer. AGLE-177 is currently being studied in a phase 1/2 clinical trial for the treatment of patients with classical homocystinuria, a rare inherited disorder of methionine metabolism that results in elevated levels of total homocysteine. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities (including severe osteoporosis), developmental delay, intellectual disability, lens dislocation and severe near sightedness. Preclinical data demonstrated that AGLE-177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. AGLE-177 has received both U.S. and EU Orphan Drug Designation as well as U.S. Rare Pediatric Disease Designation.

Photo: Anthony Quinn, outgoing president, CEO, and member of Aeglea’s board of directors

Author: Rare Daily Staff

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