Pegzilarginase is a Recombinant Enzyme owned by Aeglea BioTherapeutics, and is involved in 7 clinical trials, of which 6 were completed, and 1 is ongoing.

Pegzilarginase (AEB-1102) (AERase) is a recombinant human enzyme. It is an arginine-depleting enzyme. L-arginine is the precursor for the production of nitric oxide (NO), which may have influence tumor initiation, promotion, and progression. Normal tissues make their own arginine with the enzymes ornithine transcarbamylase (OTC), arginine succinate synthase (ASS), and arginine succinate lyase (ASL). In many tumors, silencing of these genes by DNA methylation disables arginine synthesis. As a result, these tumors must obtain arginine from the circulation for survival. The drug candidate breaks up molecules of arginine, making the amino acid unavailable as a nutrient in the bloodstream.

The revenue for Pegzilarginase is expected to reach a total of $410m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Pegzilarginase NPV Report.

Pegzilarginase is currently owned by Aeglea BioTherapeutics.

Pegzilarginase Overview

Pegzilarginase (AEB-1102) (AERase) is under development for the treatment of arginase I deficiency (Hyperargininemia), solid tumor, small cell lung cancer, cutaneous melanoma, uveal melanoma. It is administered intravenously. The drug candidate is a pegylated recombinant human arginase I. It is developed by substituting the cofactor manganese with cobalt. Recombinant arginase I act by degrading the amino acids arginine. It was under development for treatment of colon cancer, myelodysplastic syndrome, refractory and relapsed acute myeloid leukemia, hepatocellular carcinoma.

Aeglea BioTherapeutics Overview

Aeglea BioTherapeutics (Aeglea) is a biotechnology company. The company develops and commercializes human enzymes for the treatment of cancer and rare genetic diseases. The company’s lead product pipeline includes pegzilarginase (AEB1102), is used for the treatment of arginase deficiency. It also develops AGLE-177, for treating classical homocystinuria, a rare disease cause due to hereditary genetic deficiency; AGLE-324, for treating cystinuria. Aeglea also provides enzyme solutions to treat diseases with unmet medical needs. The company works in partnership with research institutions, healthcare providers and pharmaceutical companies. It caters its products across the US and the UK. Aeglea is headquartered in Austin, Texas, the US.

The company reported revenues of (US Dollars) US$18.7 million for the fiscal year ended December 2021 (FY2021). The operating loss of the company was US$65.7 million in FY2021, compared to an operating loss of US$81.5 million in FY2020. The net loss of the company was US$65.8 million in FY2021, compared to a net loss of US$80.9 million in FY2020. The company reported revenues of US$0.2 million for the third quarter ended September 2022, a decrease of 72.2% over the previous quarter.

Quick View – Pegzilarginase

Report Segments
  • Innovator
Drug Name
  • Pegzilarginase
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Genetic Disorders
  • Oncology
Key Companies
Highest Development Stage
  • Pre-Registration

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.