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AEB1102

Phase 2

Arginase I Deficiency | Small molecule | Other |Spyre Therapeutics, Inc.|Last Updated: Jul 27, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

AEB1102 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT03378531A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I DeficiencyArginase I Deficiency
COMPLETED14 Analytics
PHASE2COMPLETED
A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency
Arginase I Deficiency
NCT0337853114
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Study Endpoints

Primary Endpoints

Incidence of treatment-related adverse events
up to 4 years
Number of subjects with adverse events
weekly throughout the study, up to 14 weeks

Includes significant changes in hematology, chemistry and coagulation laboratory studies as well as in physical exam and vital signs

Secondary Endpoints

Cmax Cmin
up to 4 years
Number of subjects with a decrease from baseline in plasma arginine level
Baseline to 2, 4, 6, 8 weeks
Pharmacokinetic profile including Cmax, AUC, Tmax, T1/2 for each subject
At 15 min, 1, 2, 4, 8, 12, 24, 48, 72, and 120 hours following dose escalation
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEB1102EXPERIMENTALEach patient may receive AEB1102 administered IV for up to approximately 4 years.

Interventions

NameTypeDescription
AEB1102DRUGmodified human arginase I
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Complete treatment in Study CAEB1102-101A without experiencing any clinically significant adverse event or other unmanageable drug toxicity that would preclude continued dosing 2. Confirmation by the Investigator and the Sponsor determine that it is acceptable for the patient...

Countries:United StatesCanadaPortugalUnited Kingdom
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Frequently asked questions about AEB1102

What is AEB1102 used for?

AEB1102 is an investigational small molecule being developed for the treatment of Arginase I Deficiency, also known as hyperargininemia. It is currently in Phase 2 clinical development and has not been approved by the FDA.

What does AEB1102 target?

AEB1102 is a small molecule that targets the enzyme arginase I, which is deficient in patients with Arginase I Deficiency. By addressing this enzyme deficiency, the drug aims to reduce elevated arginine levels associated with the condition.

Who makes AEB1102?

AEB1102 is being developed by Spyre Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker SYRE.

What phase is AEB1102 in?

AEB1102 is currently in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1/2 study and a Phase 2 study, both of which are finished. The drug remains investigational and is not yet approved.

What clinical trials is AEB1102 in?

AEB1102 has been studied in two completed clinical trials: NCT02488044, a Phase 1/2 study in patients with Arginase I Deficiency, and NCT03378531, a Phase 2 study of AEB1102 (pegzilarginase) in the same patient population. Both trials enrolled patients aged 2 years and older.

Is AEB1102 the same as pegzilarginase?

Yes, AEB1102 is also known as pegzilarginase. The Phase 2 clinical trial NCT03378531 refers to the drug as AEB1102 (pegzilarginase), confirming that these names are used interchangeably for the same investigational therapy.