CELL AND GENE THERAPY

Aeglea BioTherapeutics Announces Leadership Transition and Corporate Restructuring

Aeglea BioTherapeutics, Inc. | August 25, 2022 | Read time : 04:00 min

Aeglea BioTherapeutics
Aeglea BioTherapeutics, Inc. a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced a leadership transition and corporate restructuring to focus resources on AGLE-177 in development for patients living with Homocystinuria.

The restructuring has further reduced the headcount of the Company resulting in an approximately 25% reduction year-to-date. The Company 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 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. 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."

Russell J. Cox, chair of the board of directors of Aeglea

The Company announced that Anthony Quinn, M.B., Ch.B., Ph. D., president and chief executive officer, 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, Ph.D., J.D., the Company's current general counsel, as interim president and chief executive officer as the Company 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.

Mr. Cox continued, "On behalf of the board of directors, I want to thank Anthony for his leadership and unwavering commitment to patients during his tenure. 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. 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."

"It has been an enormous privilege to have led the evolution of Aeglea from a research organization to a company with development, manufacturing and commercial capabilities," said Dr. Quinn. "I am honored to have worked with the incredible team at Aeglea and am very excited about Aeglea's upcoming milestones. I look forward to continuing my engagement with the company in an advisory role."

"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 1/2 trial for AGLE-177 later this year is our near-term focus in advancing this mission," said Mr. Kastenmayer.

About AGLE-177 in Homocystinuria
AGLE-177 is a novel recombinant human enzyme, which is 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.

About Pegzilarginase in Arginase 1 Deficiency
Pegzilarginase is a novel recombinant human enzyme engineered to degrade the amino acid arginine and has been shown to rapidly and sustainably lower levels of the amino acid arginine in plasma. Aeglea is developing pegzilarginase for the treatment of people with Arginase 1 Deficiency (ARG1-D), a rare debilitating and progressive disease characterized by the accumulation of arginine. ARG1-D presents in early childhood and patients experience spasticity, seizures, developmental delay, intellectual disability and early mortality. The PEACE Phase 3 clinical trial met its primary endpoint with a 76.7% reduction in mean plasma arginine compared to placebo. Additionally, 90.5% of pegzilarginase treated patients achieved normal plasma arginine levels. The arginine lowering was accompanied by a positive trend in Gross Motor Function Measure Part E, a measure of patient mobility.

About Aeglea BioTherapeutics
Aeglea BioTherapeutics is a clinical-stage biotechnology company redefining the potential of human enzyme therapeutics to benefit people with rare metabolic diseases with limited treatment options. Aeglea is investigating AGLE-177 in an ongoing Phase 1/2 clinical trial for the treatment of Homocystinuria. AGLE-177 has been granted Rare Pediatric Disease Designation. Aeglea's other clinical program, pegzilarginase, achieved the primary endpoint of arginine reduction in the PEACE Phase 3 clinical trial and has received both Rare Pediatric Disease and Breakthrough Therapy Designations.  Aeglea has an active discovery platform focused on engineering small changes in human enzymes to have a big impact on the lives of patients and their families.

Spotlight

The Human Genome Project (HGP-read) was initiated in December 1984 at the DOE Alta meeting and launched on October 1, 1990. Aimed at a nearly complete “reading” of the human and other genomes with annotations of plausible gene functions, as well as the improvement of the technology, cost, and quality of DNA sequencing (1, 2), it was the largest life science project ever conducted and one of the great feats of exploration in history.

Spotlight

The Human Genome Project (HGP-read) was initiated in December 1984 at the DOE Alta meeting and launched on October 1, 1990. Aimed at a nearly complete “reading” of the human and other genomes with annotations of plausible gene functions, as well as the improvement of the technology, cost, and quality of DNA sequencing (1, 2), it was the largest life science project ever conducted and one of the great feats of exploration in history.

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