Aeglea BioTherapeutics has begun dosing patients in the repeat dose part of its Phase I/II clinical trial of AEB1102 (pegzilarginase) to treat arginase 1 deficiency.

AEB1102 is an engineered human arginase 1 enzyme being developed for degradation of the amino acid arginine for the treatment of arginine excess.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The drug candidate is expected to serve as an enzyme replacement therapy to restore arginase 1 function in patients by bringing increased blood arginine levels to normal physiological range.

Designed to include a minimum of ten adult and paediatric patients, the multi-centre, single arm, open label trial will assess the safety and tolerability of intravenous pegzilarginase as the primary endpoint.

The trial will also investigate the pharmacokinetic and pharmacodynamic effects such as plasma arginine levels after administration of repeated doses of pegzilarginase.

"We are continuing our discussions with the FDA about including pediatric patients in the trial, and have initiated activities in Europe and Canada to reach more patients with this very rare disease."

Aeglea BioTherapeutics chief medical officer James Wooldridge said: “The initiation of the repeat dose part of the study is important given the encouraging initial results seen with single doses of pegzilarginase, as it will provide important insights into the effects of longer-term arginine reduction in patients with this serious and progressive disease.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“Additionally, we are continuing our discussions with the FDA about including pediatric patients in the trial, and have initiated activities in Europe and Canada to reach more patients with this very rare disease.”

In the initial Phase I part of the trial, single-ascending doses of pegzilarginase showed favourable tolerability and decreased arginine levels in the blood.

Top-line results from the Phase I/II trial are expected to be available in the second half of next year.