Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a biotechnology company advancing a pipeline of antibody therapeutics with best-in-class potential to transform the treatment of inflammatory bowel disease, today announced that it has entered into an agreement to sell the global rights to pegzilarginase, an investigational treatment for the rare metabolic disease Arginase 1 Deficiency, to Immedica Pharma AB for $15 million in upfront cash proceeds and up to $100 million in contingent milestone payments. The sale of pegzilarginase to Immedica supersedes the previous license agreement between Aeglea and Immedica.
“We are thrilled that Immedica will be continuing our efforts with pegzilarginase and consolidating development of the potential therapy for the treatment of ARG1-D,” said Jonathan Alspaugh, President and Chief Financial Officer of Aeglea. “Immedica has made substantial progress in working towards a European market approval. We believe it is ultimately in the best interest of the ARG1-D community that Immedica will seek to continue the dialogue with the FDA to discuss a path forward for pegzilarginase in the United States while advancing the program globally.”
The milestone payments are contingent on formal reimbursement decisions by national authorities in key European markets and pegzilarginase approval by the U.S. Food and Drug Administration (“FDA”), among other events. The upfront payment and contingent milestone payments if paid, net of expenses and adjustments, will be distributed to holders of Aeglea’s Contingent Value Rights (“CVR”) pursuant to the CVR agreement resulting from Aeglea’s acquisition of Spyre Therapeutics, Inc. (“Spyre”).
About Pegzilarginase in ARG1-D
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. Pegzilarginase has been in development for the treatment of people with 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. Based on the results from PEACE and a previous Phase 1/2 clinical trial, a Marketing Authorisation Application was submitted to the European Medicines Agency by Immedica. In April 2022, Aeglea announced the submission of a Biologics License Application (BLA) to the FDA. In June 2022, Aeglea announced the receipt of a Refusal to File letter from the FDA for the BLA of pegzilarginase for the treatment of ARG1-D.
About Aeglea BioTherapeutics
In June 2023, Aeglea completed the asset acquisition of Spyre and shifted its disease focus to IBD. Aeglea is advancing a pipeline of antibody therapeutics with the potential to transform the treatment of IBD. The approaches combine novel antibody engineering, rational therapeutic combinations, and precision immunology approaches to maximize efficacy, safety, and convenience of treatments for IBD.
For more information, please visit http://aeglea.com.
