“Given the frequency of ADAs seen with other proven effective enzyme therapies, we continue to believe there is a potential for pegtarviliase with further exploration in the clinic. Additional work on dosing regimens, including dose level, duration and/or frequency, could yield insights into the ability of pegtarviliase to potentially lower homocysteine into a therapeutic range, and therefore benefit people living with Homocystinuria,” said Jeffrey Goldberg, president and CEO of Aeglea. “We have produced valuable information in our clinical program for pegtarviliase that we believe ultimately benefits the Homocystinuria community but, unfortunately, we do not believe the data we currently have support immediate dialogue with regulators on a pivotal trial design. We would like to thank all the patients, caregivers, physicians and support staff that gave their time and energy to participate in our clinical trial.”
Process to Explore Strategic Alternatives
Aeglea has engaged Wedbush Securities Inc. as an exclusive financial advisor to assist in the process of exploring strategic alternatives, which will include, but are not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements will be reached or transactions will be successfully consummated or on attractive terms. The company has not set a timetable for completion of this strategic review and does not intend to comment further on the status of this process unless or until its board of directors has approved a definitive course of action, or it is determined that other disclosure is appropriate or required.
As part of this process, Aeglea is reducing its workforce and will retain approximately 10 employees required to support the process and continue ongoing value-creating activities. The company also announced the departures of Michael C. Hanley, MBA, chief business officer, and Linda Neuman, MD, MBA, chief medical officer.
“Our other clinical program, pegzilarginase for the treatment of patients with Arginase 1 Deficiency which is partnered in Europe and certain countries in the Middle East with Immedica Pharma AB, currently has a Marketing Authorization Application under review with the European Medicines Agency with a potential decision on approval in late 2023,” said Cortney Caudill, chief product officer. “This represents years of hard work from the team, and I’d like to thank all the current and former Aeglea employees for their dedication in the development of both our clinical-stage programs with the potential to positively impact the lives of people with rare metabolic diseases.”
About Pegtarviliase in Homocystinuria
Pegtarviliase is a novel recombinant human enzyme, which is engineered to reduce elevated levels of total homocysteine circulating in the plasma by degrading the amino acid homocysteine and its dimer. Pegtarviliase 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 lens dislocation, skeletal abnormalities, vascular complications and neurologic effects, as well as the potential for sudden and early death. In preclinical studies, pegtarviliase improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. Pegtarviliase has received both U.S. and EU Orphan Drug Designation as well as U.S. Rare Pediatric Disease and Fast Track Designations.
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 pegtarviliase in an ongoing Phase 1/2 clinical trial for the treatment of Classical Homocystinuria. Aeglea’s other clinical program, pegzilarginase, achieved the primary endpoint of arginine reduction in the PEACE Phase 3 clinical trial. The Marketing Authorization Application for pegzilarginase is currently under review with the European Medicines Agency. Aeglea has also developed a pipeline of engineered human enzymes that have been explored in preclinical testing, the most advanced of which is for the potential treatment of Cystinuria. For more information, please visit http://aeglea.com.